CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`
`
`APPLICATION NUMBER:
`22-272
`
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`
`
`
`
`

`

`EXCLUSIVITY SUMMARY
`
`
`NDA # 022272
`
`
`
`
`
`SUPPL #
`
`
`
`
`
`HFD # 170
`
`Trade Name OxyContin
`
`Generic Name Oxycodone Hydrochloride Controlled-Release Tablets
`
`
`
`
`
`Applicant Name Purdue Pharma L.P.
`
`Approval Date, If Known April 5, 2010
`
`PART I
`
`1. An exclusivity determination will be made for all original applications, and all efficacy
`supplements. Complete PARTS II and III of this Exclusivity Summary only if you answer "yes" to
`one or more of the following questions about the submission.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IS AN EXCLUSIVITY DETERMINATION NEEDED?
`
`a) Is it a 505(b)(1), 505(b)(2) or efficacy supplement?
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`If yes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4, SE5, SE6, SE7, SE8
`
`
`
`505(b)(1)
`
`c) Did it require the review of clinical data other than to support a safety claim or change in
`labeling related to safety? (If it required review only of bioavailability or bioequivalence
`data, answer "no.")
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`If your answer is "no" because you believe the study is a bioavailability study and, therefore,
`not eligible for exclusivity, EXPLAIN why it is a bioavailability study, including your
`reasons for disagreeing with any arguments made by the applicant that the study was not
`simply a bioavailability study.
`
`
`This is a reformulation of the original OxyContin (under NDA 020553). The new
`formulation was compared to the original formulation in comparative bioavailability studies.
`This new formulation was shown to be bioequivalent to the original formulation. No clinical
`studies were performed.
`
`If it is a supplement requiring the review of clinical data but it is not an effectiveness
`supplement, describe the change or claim that is supported by the clinical data:
`
`
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`Page 1
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`

`

`
`
`
`
`
`
`d) Did the applicant request exclusivity?
`
`
`
`
`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
`
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`e) Has pediatric exclusivity been granted for this Active Moiety?
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`
` If the answer to the above question in YES, is this approval a result of the studies submitted in
`response to the Pediatric Written Request?
`
`
`
`IF YOU HAVE ANSWERED "NO" TO ALL OF THE ABOVE QUESTIONS, GO DIRECTLY TO
`THE SIGNATURE BLOCKS AT THE END OF THIS DOCUMENT.
`
`
`2. Is this drug product or indication a DESI upgrade?
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`IF THE ANSWER TO QUESTION 2 IS "YES," GO DIRECTLY TO THE SIGNATURE BLOCKS
`ON PAGE 8 (even if a study was required for the upgrade).
`
`
`FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES
`PART II
`(Answer either #1 or #2 as appropriate)
`
`1. Single active ingredient product.
`
`Has FDA previously approved under section 505 of the Act any drug product containing the same
`active moiety as the drug under consideration? Answer "yes" if the active moiety (including other
`esterified forms, salts, complexes, chelates or clathrates) has been previously approved, but this
`particular form of the active moiety, e.g., this particular ester or salt (including salts with hydrogen or
`coordination bonding) or other non-covalent derivative (such as a complex, chelate, or clathrate) has
`not been approved. Answer "no" if the compound requires metabolic conversion (other than
`deesterification of an esterified form of the drug) to produce an already approved active moiety.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`
`Page 2
`
`

`

`#(s).
`
`Code RLD Active Ingredient
`
`Appl
`TE
`No
`A040199 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040289 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040303 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040257 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A088790 AA Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040061 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040106 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040234 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040680 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`Dosage Form;
`Route
`CAPSULE;
`ORAL
`
`Strength
`500MG;5MG
`
`Proprietary
`Name
`OXYCODONE AND
`ACETAMINOPHEN
`
`Applicant
`
`ACTAVIS
`TOTOWA
`
`CAPSULE;
`ORAL
`
`CAPSULE;
`ORAL
`
`CAPSULE;
`ORAL
`
`CAPSULE;
`ORAL
`
`CAPSULE;
`ORAL
`
`CAPSULE;
`ORAL
`
`CAPSULE;
`ORAL
`
`500MG;5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`DURAMED
`PHARMS BARR
`
`500MG;5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`ENDO PHARMS
`
`500MG;5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`MALLINCKRODT
`
`500MG;5MG
`
`TYLOX
`
`ORTHO MCNEIL
`JANSSEN
`
`500MG;5MG
`
`ROXILOX
`
`ROXANE
`
`500MG;5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`VINTAGE PHARMS
`
`500MG;5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`WATSON LABS
`
`SOLUTION;
`ORAL
`
`325MG/5ML;5MG/5ML OXYCODONE AND
`ACETAMINOPHEN
`
`MALLINCKRODT
`
`A089351 AA Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`SOLUTION;
`ORAL
`
`325MG/5ML;5MG/5ML ROXICET
`
`ROXANE
`
`A040203 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040778 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`325MG;5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`ACTAVIS
`TOTOWA
`
`TABLET; ORAL
`
`325MG;10MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`AMNEAL PHARMS
`NY
`
`
`
`
`Page 3
`
`

`

`A040777 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040789 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040789 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A090177 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A090177 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A090177 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A090177 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A090177 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A090177 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040434 AA Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040330 AA Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040330 AA Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040434 AA Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`325MG;5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`AMNEAL PHARMS
`NY
`
`TABLET; ORAL
`
`500MG;7 5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`AMNEAL PHARMS
`NY
`
`TABLET; ORAL
`
`650MG;10MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`AMNEAL PHARMS
`NY
`
`TABLET; ORAL
`
`325MG;10MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`COASTAL
`PHARMS
`
`TABLET; ORAL
`
`325MG;2 5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`COASTAL
`PHARMS
`
`TABLET; ORAL
`
`325MG;5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`COASTAL
`PHARMS
`
`TABLET; ORAL
`
`325MG;7 5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`COASTAL
`PHARMS
`
`TABLET; ORAL
`
`500MG;7 5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`COASTAL
`PHARMS
`
`TABLET; ORAL
`
`650MG;10MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`COASTAL
`PHARMS
`
`TABLET; ORAL
`
`325MG;10MG
`
`PERCOCET
`
`ENDO PHARMS
`
`TABLET; ORAL
`
`325MG;2 5MG
`
`PERCOCET
`
`ENDO PHARMS
`
`TABLET; ORAL
`
`325MG;5MG
`
`PERCOCET
`
`ENDO PHARMS
`
`TABLET; ORAL
`
`325MG;7 5MG
`
`PERCOCET
`
`ENDO PHARMS
`
`
`
`
`Page 4
`
`

`

`A040341 AA Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040341 AA Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040545 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A087463 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040545 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040550 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040550 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040608
`
`Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040608
`
`Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040608
`
`Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040608
`
`Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040692
`
`Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040679
`
`Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`500MG;7 5MG
`
`PERCOCET
`
`ENDO PHARMS
`
`TABLET; ORAL
`
`650MG;10MG
`
`PERCOCET
`
`ENDO PHARMS
`
`TABLET; ORAL
`
`325MG;10MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`MALLINCKRODT
`
`TABLET; ORAL
`
`325MG;5MG
`
`OXYCET
`
`MALLINCKRODT
`
`TABLET; ORAL
`
`325MG;7 5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`MALLINCKRODT
`
`TABLET; ORAL
`
`500MG;7 5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`MALLINCKRODT
`
`TABLET; ORAL
`
`650MG;10MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`MALLINCKRODT
`
`TABLET; ORAL
`
`300MG;10MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`TABLET; ORAL
`
`300MG;2 5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`TABLET; ORAL
`
`300MG;5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`TABLET; ORAL
`
`300MG;7 5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`TABLET; ORAL
`
`400MG;10MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`TABLET; ORAL
`
`400MG;2 5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`MIKART
`
`MIKART
`
`MIKART
`
`MIKART
`
`MIKART
`
`MIKART
`
`
`
`
`Page 5
`
`

`

`A040687
`
`Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040698
`
`Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040676
`
`No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A087003 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A089775
`
`Yes ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040105 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040535 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040171 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040535 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040371 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`A040371 AA No ACETAMINOPHEN;
`OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`400MG;5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`TABLET; ORAL
`
`400MG;7 5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`TABLET; ORAL
`
`500MG;10MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`MIKART
`
`MIKART
`
`MIKART
`
`TABLET; ORAL
`
`325MG;5MG
`
`ROXICET
`
`ROXANE
`
`TABLET; ORAL
`
`500MG;5MG
`
`ROXICET 5/500
`
`ROXANE
`
`TABLET; ORAL
`
`325MG;5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`VINTAGE PHARMS
`
`TABLET; ORAL
`
`325MG;10MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`WATSON LABS
`
`TABLET; ORAL
`
`325MG;5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`WATSON LABS
`
`TABLET; ORAL
`
`325MG;7 5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`WATSON LABS
`
`TABLET; ORAL
`
`500MG;7 5MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`WATSON LABS
`
`TABLET; ORAL
`
`650MG;10MG
`
`OXYCODONE AND
`ACETAMINOPHEN
`
`WATSON LABS
`
`N007337
`
`Yes ASPIRIN; OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`325MG;4 8355MG
`
`PERCODAN
`
`ENDO PHARMS
`
`N007337 AA Yes ASPIRIN; OXYCODONE
`HYDROCHLORIDE;
`OXYCODONE
`TEREPHTHALATE
`
`TABLET; ORAL
`
`325MG;4 5MG;0 38MG PERCODAN
`
`ENDO PHARMS
`
`
`
`
`Page 6
`
`

`

`A040255 AA No ASPIRIN; OXYCODONE
`HYDROCHLORIDE;
`OXYCODONE
`TEREPHTHALATE
`
`TABLET; ORAL
`
`325MG;4 5MG;0 38MG OXYCODONE AND
`ASPIRIN
`
`WATSON LABS
`
`A078769 AB No
`
`IBUPROFEN; OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`400MG;5MG
`
`A078316 AB No
`
`IBUPROFEN; OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`400MG;5MG
`
`OXYCODONE
`HYDROCHLORIDE AND
`IBUPROFEN
`
`ACTAVIS
`ELIZABETH
`
`OXYCODONE
`HYDROCHLORIDE AND
`IBUPROFEN
`
`BARR
`
`N021378 AB Yes
`
`IBUPROFEN; OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`400MG;5MG
`
`COMBUNOX
`
`FOREST LABS
`
`A078394 AB No
`
`IBUPROFEN; OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`400MG;5MG
`
`A077822 AB No OXYCODONE
`HYDROCHLORIDE
`
`A077822 AB No OXYCODONE
`HYDROCHLORIDE
`
`A077822 AB No OXYCODONE
`HYDROCHLORIDE
`
`A077822 AB No OXYCODONE
`HYDROCHLORIDE
`
`N020553 AB No OXYCODONE
`HYDROCHLORIDE
`
`N020553
`
`No OXYCODONE
`HYDROCHLORIDE
`
`N020553 AB No OXYCODONE
`HYDROCHLORIDE
`
`10MG
`
`20MG
`
`40MG
`
`80MG
`
`10MG
`
`15MG
`
`20MG
`
`TABLET,
`EXTENDED
`RELEASE;
`ORAL
`
`TABLET,
`EXTENDED
`RELEASE;
`ORAL
`
`TABLET,
`EXTENDED
`RELEASE;
`ORAL
`
`TABLET,
`EXTENDED
`RELEASE;
`ORAL
`
`TABLET,
`EXTENDED
`RELEASE;
`ORAL
`
`TABLET,
`EXTENDED
`RELEASE;
`ORAL
`
`TABLET,
`EXTENDED
`RELEASE;
`ORAL
`
`OXYCODONE
`HYDROCHLORIDE AND
`IBUPROFEN
`
`WATSON LABS
`
`OXYCODONE
`HYDROCHLORIDE
`
`MALLINCKRODT
`
`OXYCODONE
`HYDROCHLORIDE
`
`MALLINCKRODT
`
`OXYCODONE
`HYDROCHLORIDE
`
`MALLINCKRODT
`
`OXYCODONE
`HYDROCHLORIDE
`
`MALLINCKRODT
`
`OXYCONTIN
`
`PURDUE PHARMA
`LP
`
`OXYCONTIN
`
`PURDUE PHARMA
`LP
`
`OXYCONTIN
`
`PURDUE PHARMA
`LP
`
`
`
`
`Page 7
`
`

`

`N020553
`
`No OXYCODONE
`HYDROCHLORIDE
`
`N020553 AB Yes OXYCODONE
`HYDROCHLORIDE
`
`N020553
`
`No OXYCODONE
`HYDROCHLORIDE
`
`N020553 AB No OXYCODONE
`HYDROCHLORIDE
`
`30MG
`
`40MG
`
`60MG
`
`80MG
`
`TABLET,
`EXTENDED
`RELEASE;
`ORAL
`
`TABLET,
`EXTENDED
`RELEASE;
`ORAL
`
`TABLET,
`EXTENDED
`RELEASE;
`ORAL
`
`TABLET,
`EXTENDED
`RELEASE;
`ORAL
`
`OXYCONTIN
`
`PURDUE PHARMA
`LP
`
`OXYCONTIN
`
`PURDUE PHARMA
`LP
`
`OXYCONTIN
`
`PURDUE PHARMA
`LP
`
`OXYCONTIN
`
`PURDUE PHARMA
`LP
`
`A076636 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`15MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`ACTAVIS
`TOTOWA
`
`A076636 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`30MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`ACTAVIS
`TOTOWA
`
`A091393 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`10MG
`
`A091393 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`15MG
`
`A091393 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`20MG
`
`A091393 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`30MG
`
`A091393 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`5MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`OXYCODONE
`HYDROCHLORIDE
`
`OXYCODONE
`HYDROCHLORIDE
`
`OXYCODONE
`HYDROCHLORIDE
`
`OXYCODONE
`HYDROCHLORIDE
`
`AVANTHI INC
`
`AVANTHI INC
`
`AVANTHI INC
`
`AVANTHI INC
`
`AVANTHI INC
`
`A090895 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`15MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`COREPHARMA
`
`A090895 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`30MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`COREPHARMA
`
`A090895 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`5MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`COREPHARMA
`
`
`
`
`Page 8
`
`

`

`A077290 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`10MG
`
`A077290 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`15MG
`
`A077290 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`20MG
`
`A077290 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`30MG
`
`A077290 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`5MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`OXYCODONE
`HYDROCHLORIDE
`
`OXYCODONE
`HYDROCHLORIDE
`
`OXYCODONE
`HYDROCHLORIDE
`
`OXYCODONE
`HYDROCHLORIDE
`
`KV PHARM
`
`KV PHARM
`
`KV PHARM
`
`KV PHARM
`
`KV PHARM
`
`A076758 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`15MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`MALLINCKRODT
`
`A076758 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`30MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`MALLINCKRODT
`
`A090659 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`15MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`SUN PHARM INDS
`INC
`
`A090659 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`30MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`SUN PHARM INDS
`INC
`
`A090659 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`A078206 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`5MG
`
`5MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`SUN PHARM INDS
`INC
`
`OXYCODONE
`HYDROCHLORIDE
`
`TYCO HLTHCARE
`
`A077712 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`15MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`VINTAGE PHARMS
`
`A077712 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`30MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`VINTAGE PHARMS
`
`A077712 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`5MG
`
`OXYCODONE
`HYDROCHLORIDE
`
`VINTAGE PHARMS
`
`N021011 AB Yes OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`15MG
`
`ROXICODONE
`
`N021011 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`30MG
`
`ROXICODONE
`
`XANODYNE
`PHARMS
`
`XANODYNE
`PHARMS
`
`
`
`
`Page 9
`
`

`

`N021011 AB No OXYCODONE
`HYDROCHLORIDE
`
`TABLET; ORAL
`
`5MG
`
`ROXICODONE
`
`XANODYNE
`PHARMS
`
`
`
`
`2. Combination product.
`
`If the product contains more than one active moiety(as defined in Part II, #1), has FDA previously
`approved an application under section 505 containing any one of the active moieties in the drug
`product? If, for example, the combination contains one never-before-approved active moiety and
`one previously approved active moiety, answer "yes." (An active moiety that is marketed under an
`OTC monograph, but that was never approved under an NDA, is considered not previously
`approved.)
`
`
`
`
`
`YES
`
`
`
`NO
`
`
`
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
`
`NDA#
`NDA#
`NDA#
`
`
`IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART II IS "NO," GO DIRECTLY TO THE
`SIGNATURE BLOCKS ON PAGE 8. (Caution: The questions in part II of the summary should
`only be answered “NO” for original approvals of new molecular entities.)
`IF “YES,” GO TO PART III.
`
`
`PART III
`
`To qualify for three years of exclusivity, an application or supplement must contain "reports of new
`clinical investigations (other than bioavailability studies) essential to the approval of the application
`and conducted or sponsored by the applicant." This section should be completed only if the answer
`to PART II, Question 1 or 2 was "yes."
`
`
`1. Does the application contain reports of clinical investigations? (The Agency interprets "clinical
`investigations" to mean investigations conducted on humans other than bioavailability studies.) If
`the application contains clinical investigations only by virtue of a right of reference to clinical
`investigations in another application, answer "yes," then skip to question 3(a). If the answer to 3(a)
`is "yes" for any investigation referred to in another application, do not complete remainder of
`summary for that investigation.
`
`
`
`
`
`
`
`
`
`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
`
`
`
`
`
`YES
`
`
`
`NO
`
`
`
`
`
`
`Page 10
`
`

`

`
`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8.
`
`2. A clinical investigation is "essential to the approval" if the Agency could not have approved the
`application or supplement without relying on that investigation. Thus, the investigation is not
`essential to the approval if 1) no clinical investigation is necessary to support the supplement or
`application in light of previously approved applications (i.e., information other than clinical trials,
`such as bioavailability data, would be sufficient to provide a basis for approval as an ANDA or
`505(b)(2) application because of what is already known about a previously approved product), or 2)
`there are published reports of studies (other than those conducted or sponsored by the applicant) or
`other publicly available data that independently would have been sufficient to support approval of
`the application, without reference to the clinical investigation submitted in the application.
`
`
`(a) In light of previously approved applications, is a clinical investigation (either conducted
`by the applicant or available from some other source, including the published literature)
`necessary to support approval of the application or supplement?
`
`
` YES
`
`
`If "no," state the basis for your conclusion that a clinical trial is not necessary for approval
`AND GO DIRECTLY TO SIGNATURE BLOCK ON PAGE 8:
`
`
`
`NO
`
`
`
`
`
`(b) Did the applicant submit a list of published studies relevant to the safety and effectiveness
`of this drug product and a statement that the publicly available data would not independently
`support approval of the application?
`
`
`
`
`
`
`(1) If the answer to 2(b) is "yes," do you personally know of any reason to disagree
`with the applicant's conclusion? If not applicable, answer NO.
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`
`
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
` If yes, explain:
`
`
`
`
`
`(2) If the answer to 2(b) is "no," are you aware of published studies not conducted or
`sponsored by the applicant or other publicly available data that could independently
`demonstrate the safety and effectiveness of this drug product?
`
`
`
`
`
`
`
` If yes, explain:
`
`
`
`
`
`
` YES
`
`
`
`NO
`
`
`
`
`
`
`Page 11
`
`

`

`
`
`(c)
`
`If the answers to (b)(1) and (b)(2) were both "no," identify the clinical investigations
`submitted in the application that are essential to the approval:
`
`
`
`
`
`Studies comparing two products with the same ingredient(s) are considered to be bioavailability
`studies for the purpose of this section.
`
`
`3. In addition to being essential, investigations must be "new" to support exclusivity. The agency
`interprets "new clinical investigation" to mean an investigation that 1) has not been relied on by the
`agency to demonstrate the effectiveness of a previously approved drug for any indication and 2) does
`not duplicate the results of another investigation that was relied on by the agency to demonstrate the
`effectiveness of a previously approved drug product, i.e., does not redemonstrate something the
`agency considers to have been demonstrated in an already approved application.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`a) For each investigation identified as "essential to the approval," has the investigation been
`relied on by the agency to demonstrate the effectiveness of a previously approved drug
`product? (If the investigation was relied on only to support the safety of a previously
`approved drug, answer "no.")
`
`Investigation #1
`
`Investigation #2
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`YES
`
`YES
`
`
`
`
`
`NO
`
`NO
`
`
`
`
`
`If you have answered "yes" for one or more investigations, identify each such investigation
`and the NDA in which each was relied upon:
`
`
`
`Investigation #1
`
`Investigation #2
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`YES
`
`YES
`
`
`
`
`
`NO
`
`NO
`
`
`
`
`
`
`b) For each investigation identified as "essential to the approval", does the investigation
`duplicate the results of another investigation that was relied on by the agency to support the
`effectiveness of a previously approved drug product?
`
`
`
`
`
`
`
`
`If you have answered "yes" for one or more investigation, identify the NDA in which a
`
`Page 12
`
`

`

`
`
`
`
`
`
`similar investigation was relied on:
`
`
`
`c) If the answers to 3(a) and 3(b) are no, identify each "new" investigation in the application
`or supplement that is essential to the approval (i.e., the investigations listed in #2(c), less any
`that are not "new"):
`
`
`
`
`
`
`
`4. To be eligible for exclusivity, a new investigation that is essential to approval must also have
`been conducted or sponsored by the applicant. An investigation was "conducted or sponsored by"
`the applicant if, before or during the conduct of the investigation, 1) the applicant was the sponsor of
`the IND named in the form FDA 1571 filed with the Agency, or 2) the applicant (or its predecessor
`in interest) provided substantial support for the study. Ordinarily, substantial support will mean
`providing 50 percent or more of the cost of the study.
`
`
`Investigation #1
`
`
`
`IND #
`
`
`
`
`
`
`
`
`
`
`YES
`
`
`Investigation #2
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`a) For each investigation identified in response to question 3(c): if the investigation was
`carried out under an IND, was the applicant identified on the FDA 1571 as the sponsor?
`
`!
`!
`
`! NO
`! Explain:
`
`
`
`!
`!
`
`! NO
`! Explain:
`
`
`
`
`
`
`
`
`
`YES
`
`
`IND #
`
`
`
`
`
`
`
`
`
`
`
`
`(b) For each investigation not carried out under an IND or for which the applicant was not
`identified as the sponsor, did the applicant certify that it or the applicant's predecessor in
`interest provided substantial support for the study?
`
`
`
`
`
`
`Investigation #1
`
`
`
`
`
`!
`!
`
`
`
`
`Page 13
`
`

`

`
`
`
`
`YES
`Explain:
`
`
`
`Investigation #2
`
`YES
`
`Explain:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`! NO
`! Explain:
`
`
`
`!
`!
`
`! NO
`! Explain:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`(c) Notwithstanding an answer of "yes" to (a) or (b), are there other reasons to believe that
`the applicant should not be credited with having "conducted or sponsored" the study?
`(Purchased studies may not be used as the basis for exclusivity. However, if all rights to the
`drug are purchased (not just studies on the drug), the applicant may be considered to have
`sponsored or conducted the studies sponsored or conducted by its predecessor in interest.)
`
`
`
`
`
`
`YES
`
`
`
`NO
`
`
`
`If yes, explain:
`
`
`
`
`
`
`
`
`=================================================================
`
`Name of person completing form: Lisa Basham
`Title: Senior Regulatory Health Project Manager
`Date: 3/31/10
`
`
`Name of Office/Division Director signing form: Bob A. Rappaport, MD
`Title: Director, Division of Anesthesia and Analgesia Products
`
`
`
`Form OGD-011347; Revised 05/10/2004; formatted 2/15/05
`
`
`
`
`
`Page 14
`
`

`

`Application
`Type/Number
`--------------------
`NDA-22272
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`PURDUE PHARMA
`INC
`
`------------------------------------------
`OXYCONTIN
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`LISA E BASHAM
`04/05/2010
`
`BOB A RAPPAPORT
`04/05/2010
`
`

`

`Page 1 of 1
`
`Basham, Lisa
`
`From:
`Basham, Lisa
`Sent:
`Monday, April 26, 2010 3:19 PM
`To:
`'Connelly, Beth'
`Subject:
`Correction to March 18, 2010 REMS comments.
`Attachments: revised survey comments.doc
`
`Beth, Regarding the REMS comments that were sent to you on March 18, 2010, those comments included
`detailed plans to be used to evaluate patients', prescribers', and pharmacists' understanding about the risks
`associated with and safe use of OxyContin. Upon further review, we have determined that a pharmacist survey is
`not necessary because the target audience for the mailing and educational materials includes only prescribers.
`Therefore, the pharmacist survey will not be necessary. Attached is a revised assessment tool that has the word
`"pharmacist" removed.
`
`Warm Regards,
`
`Lisa Basham, MS
`Senior Regulatory Health Project Manager
`Division of Anesthesia and Analgesia Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`301-796-1175
`email: lisa.basham@fda.hhs.gov
`
`
`
`4/27/2010
`
`

`

`Application
`Type/Number
`--------------------
`NDA-22272
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`PURDUE PHARMA
`INC
`
`------------------------------------------
`OXYCONTIN
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`LISA E BASHAM
`04/27/2010
`
`

`

`
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`ACKNOWLEDGE CLASS 1 COMPLETE RESPONSE
`
`
`NDA 022272
`
`
`
`Purdue Pharma L.P.
`One Stamford Forum
`Stamford, CT 06901-3431
`
`Attention: Craig Landau, M.D.
`
`CMO & VP Clinical, Medical & Regulatory Affairs
`
`
`Dear Dr. Landau:
`
`We acknowledge receipt on February 5, 2010, of your February 5, 2010, resubmission to your
`new drug application for OxyContin (oxycodone hydrochloride) Controlled-Release Tablets.
`
`We consider this a complete, class 1 response to our December 30, 2009, action letter.
`Therefore, the user fee goal date is April 5, 2010.
`
`If you have any questions, call me at (301) 796-1175.
`
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Lisa E. Basham, MS
`Senior Regulatory Project Manager
`Division of Anesthesia, Analgesia and
` Rheumatology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`

`

`Application
`Type/Number
`--------------------
`NDA-22272
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`PURDUE PHARMA
`INC
`
`------------------------------------------
`OXYCONTIN
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`LISA E BASHAM
`02/21/2010
`
`

`

`
`
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`DISCIPLINE REVIEW LETTER
`
`
`NDA 022272
`
`Purdue Pharma L.P.
`One Stamford Forum
`Stamford, CT 06901-3431
`
`Attention: Craig Landau, M.D.
`
`CMO & VP Clinical, Medical & Regulatory Affairs
`
`
`Dear Dr. Landau:
`
`Please refer to your New Drug Application (NDA) submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act for OxyContin (oxycodone hydrochloride) Controlled-Release
`Tablets.
`
`We also refer to your February 5, 2010, response to our December 30, 2009, Complete Response
`Letter.
`
`Our review of the package insert and carton and container labels from the Chemistry,
`Manufacturing and Controls perspective is complete, and we have identified the following
`deficiencies:
`
`
`1. Revise the DESCRIPTION section of the labeling to state that the new OxyContin
`formulations
`
`
` Alternately, remove the statement completely as you are not
`using the name from the official monograph.
`
`2. For each strength of the drug product, revise and resubmit the mock-ups of the bottle
`labels such that it is clear where the lot number and expiration date will be located.
`Although the location had been clear in earlier versions of the bottle labels, it is not clear
`in the latest version supplied with the February 4, 2010, amendment.
`
`
`We are providing these comments to you before we complete our review of the entire application
`to give you preliminary notice of issues that we have identified. In conformance with the
`prescription drug user fee reauthorization agreements, these comments do not reflect a final
`decision on the information reviewed and should not be construed to do so. These comments are
`preliminary and subject to change as we finalize our review of your application. In addition, we
`may identify other information that must be provided before we can approve this application. If
`you respond to these issues during this review cycle, depending on the timing of your response,
`
`
`
`(b) (4)
`
`

`

`NDA 022272
`Page 2
`
`
`and in conformance with the user fee reauthorization agreements, we may not be able to consider
`your response before we take an action on your application during this review cycle.
`
`If you have any questions, call Lisa Basham, Senior Regulatory Project Manager, at (301) 796-
`1175.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Parinda Jani
`Chief, Project Management Staff
`Division of Anesthesia, Analgesia and
` Rheumatology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`
`
`
`
`

`

`Application
`Type/Number
`--------------------
`NDA-22272
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`PURDUE PHARMA
`INC
`
`------------------------------------------
`OXYCONTIN
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`PARINDA JANI
`02/19/2010
`
`

`

`
`
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`DISCIPLINE REVIEW LETTER
`
`
`NDA 022272
`
`
`Purdue Pharma LP
`One Stamford Forum
`Stamford, CT 06901-3431
`
`Attention: Craig Landau, M.D.
`
`CMO & VP Clinical, Medical & Regulatory Affairs
`
`
`
`Dear Dr. Landau:
`
`Please refer to your New Drug Application (NDA) submitted under section 505(b) of the Federal
`Food,