`RESEARCH
`
`
`APPLICATION NUMBER:
`022272Orig1s027
`
`CHEMISTRY REVIEW(S)
`
`
`
`
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`
`
`DPMA I, BRANCH I
`
`
`OFFICE OF LIFE CYCLE PRODUCTS
`
`‘ Review of Chemistry, Manufacturing, and Controls
`
`Ciinic-al Review Division. Analgesic, Anesthesia and Addiction Products (I[FD-510)
`
`NDA#
`22-272
`REVIEW#.1
`REVIEW DATE:
`5/10/2015
`SUBMISSION TYPE
`DOCUMENT DATE
`CDER DATE
`ASSIGNED
`S-027 (Efficacy)
`12/10/2014
`12/10/2014
`05/08/2015
`1 AMENDMENT
`PDUFA GOAL
`-
`
`04/02/2015
`05/06/201 5
`
`06/10/2015
`
`NAME & ADDRESS OF APPLICANT:
`Purdue Pharma LP.
`201 Tresscr Blvd
`
`Stamford, CT 06901-3431
`
`Beth Conneliy, Associate Director, Regulatory Affairs
`Phone: 203-588-«7289
`
`DRUG PRODUCT NAME
`Progrietagr:
`Nonproprietary/USAN:
`
`FAX: 203-588—6229
`_
`.
`OxyContin® Tablets
`oxycodone HCI extended release tablets
`
`PHARMACOLOGICAL CATEGORY/INDICATION: Management of Severe pain
`
`;
`
`;
`E
`
`DOSAGE FORM:
`STRENGTH:
`
`' Extended Release Tabiet
`10, 15, 20, 30, 40, 60 and 80mg
`
`ROUTE OF ADMINISTRATION:
`DISPENSED:
`SPECIAL PRODUCTS:
`
`Oral
`
`X Rx
`_ Yes
`
`_ orc
`__)_(~_ NO
`
`I CHEMICAL NAME, STRUCTURAL FORMULA, MOLECULAR FORMULA,
`MOL. WT:
`
`Chemical Name:
`Molecular Formula:
`Molecular Weight:
`
`4,5-epoxy-14-hydroxy-3-methoxy-l 7-n1etl1yimorphinan-é-one hydrochloride
`C ”H; mm; HCl
`351.82
`
`[3’9
`
`
`
`Reference ID: 381 0536
`
`
`
`NDA 22-272 5-027
`OxyContin'm Extended Release Tablets (10, 15, 20, 30, 40, 60 and 80 mg Oxycodone HCI)
`Purdue Pharma LP.
`
`[BOVIDES FOR: (1) Labeling changes based on the pediatric studies to fulfill the Pediatric
`Written Request #3, Amendment #2;—
`—
`~
`
`REMARKS/COMMENTS:
`
`In the supplement, the applicant submitted the Pediatric Study Reports to support the requested
`pediatric exclusivity. The supplement also provides for the labeling changes based on the
`clinical studies in accordance with the November 14, 2011 Written Request #3, Amendment #2.
`
`
`
`Reference ID: 381 0536
`
`
`
`NDA 22-272 S4127
`OxyContinC' Extended Release Tablets (10, 15, 20, 30, 40, 60 and 80 mg Oxycodone HCl)
`Purdue Pharma L.P.
`
`
`
`CONSULT REVIEWS: N/A
`
`COMJVIENTS/REQUESTS TO BE CQNVEYED TO APPLICANT: N/A
`
`CONCLUSIONS & RECOMMENDATIONS:
`
`Based on the information provided by the appiieant, it appears that Purdue Pharma has made
`
`(see attached electronic signature page)
`
`Reference ID: 381 0536
`
`
`
`
`NBA 22-272 S—027
`
`
`OxyContin® Extended Release Tablets (10,15, 20, 30, 40, 60 and 80 mg OxycodOne HCI)
`
`
`
`
`
`
`
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`
`
`Purdue Pharma L.P.
`
`
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`
`
`Zed O n g
`
`
`
`-
`D
`ong S 5;;
`
`,
`
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`
`i Digitaily signed by Zedong Dong -5
`
`
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`
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`’15DN:c=US.o:U.S.Govemment,
`
`
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`
`
`3; cu:HHS, ounFDA ou=People,
`
`
`
`
`
`x:
`
`
`
`3?: 1£n=Zedong DongS.
`13m
`use§421920030010011200034185
`Date: 2015.05.11 10:48:10 04'00'
`
`
`
`
`
`
`
`
`Zedong Dong, Ph.D.
`
`
`
`Quality Assessment Lead (Acting)
`
`
`
`
`Digitally signed by flamesh Haghavacharl S
`
`
`
`:11 EN: c=US n:US Gnuernrnent. ou—HHS,
`Ra m es h
`
`
`
`
`
`
`
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`jkou:—FDA. uu=Peopie.
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`(032.1342.19200300.100”]1:1300211793
`
`
`
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`
`
`Da‘e:20l5..05l111:30:57-0-1'00
`Ra g hava c h a ri 75’"in—'='1:amesh Raghavachavi -S
`
`
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`
`Ramesh Raghavaehari, PhD.
`
`
`Chief, Branch I
`
`
`
`\ cc:
`
`
`
`
`
`Orig. NDA#22272
`
`OLDP/DPMA URRAGHAVACHARI
`
`
`OLDP/DPMA I/ZDONG
`
`
`
`Reference ID: 3810536
`Reference ID: 3810536
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MARY GRACE LUBAO
`08/24/2015
`
`Reference ID: 3810536
`
`
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