CENTER FOR DRUG EVALUATION AND RESEARCH
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`Application Number: 11522, S010
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`APPROVAL LETTER
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`T:-_'_'—
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`Amerigen Ex. 1065, p. 1
`Amerigen Ex. 1065,
`1
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`

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`‘
`0 RIM ll-522 l S-Oil}
`Richwood Pharmaceutteelfompam-.lnc.
`Attention: William A. Nut.-rye _r
`Chief Operating Officer
`'_
`7900 Tanner‘: Gate Drive. Suite 2m
`Florence. KY -ii 042
`
`Dear Mr. Nucrne:
`
`“P I 3 lfi
`
`Please refer to your supplemental new drug application of September 21. I995 (5-010).
`submitted under section 505ihl of the Federal Food. Drug. and Cosmetic Act for Adderall
`(deatroamphetamine aaccharste. deatroamphetstnine sulfate. amphetamine aapsnate. and
`arnphetarnlne sulfate) in mg and 10 mg tablets.
`
`.
`Supplemental application S-"h consists oftlte reaubrnisaion
`and provides critical analyses for the qttantlttttiort oi'd- anti l-amphetamine. and updated
`manufacturing. controls and test procedures. The supplemental spplication also provides draft
`labeling revised in response to the Efil:lll.Bui.|m notice of August I. 1970 (DESI 5373}.
`classifying this drug effective for use in the treatment of narcolepsy. attention deilelt disorder
`with hyperactivity. and exogenous obesity.
`
`0 We have completed the review of this supplemental application including the sttbrnitted draft
`
`labeling and have cottclitded that adequate information has been presented to demonstrate that
`the drug product is safe and effective for use as reeottttttetttleti with the labeling changes listed
`below. Accordingly. use application. with these labeling revisions. is approved effective as oi
`lhi! date oi‘ this letter. This action also approves this application on the basis of effeetlvetteas
`or the tint; as tvsil as safety sndfsupenedes the Federal Register nntiee ofseptetnoer 15.
`1973. thus re-establishing the approval oi’ NBA ll-$22.
`
`The labeling mutant. as agreed to by Rob Falconer of your tin-n timing tits telephone
`conversation with Steven D. lisrdentan. R.Ph.. or this agency on January 25. 1996. are r '
`follows:
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`I .
`
`2.
`
`grrnvils
`The staterrtent currently placed in Warnings. “Clinical experience suggests
`should be monitored during treatment.“ should not he repeated under Preeautton»
`Pediatric Use.
`
`I-’D.ItC Yellow so cousin; allergic reactions is
`‘lite statement under Preeeitttons that
`unnecessary and tthoulsl be deleted. as this statement applies to FD&C Yellow as rather
`than I6.
`I
`
`aA
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`Amerigen Ex. 1065, p. 2
`merigen Ex. 1065, p. 2
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`0 NBA ii-$2213-“I0
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`3.
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`Under Adverse Rcsctmm»-Ctutiiovucultr. the statentenl. "There have been isolated
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`2
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`reports of cerdiomyopothy sxsoeiated with chronic nmpheiurnine use." should be coded
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`4.
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`The treatment ofoverdnutge section should be updated. on follows:
`(additions are in redltne lttnl. deletions are in strikcoiti font)
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`OVERDOSAGE:
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`TREATMENT-Consult with a Certified Poison Control Center f‘oI'tlEi.o'date guidance
`and advice: Management of acute amphetamine intoxication it lsrneiy symptomatic and
`includes gastric lavage. administration of activsted charcoal. administration of a cathartic
`and sedation
`F.xperlence with hemodteiysis or peritoneal dialysis is
`inadequate to permit recontntentlation in this rcgnrd. Acidification ol’ the urine inerenes
`amphetlrnine excretion. but is believed to lnerettae rlalt ofncutc renal failure If
`rnyoglohinttrle is present.
`if acute. severe hype-rtensiorr complicates ernpltctsrnine
`nverdosage. administration at’ intravenous phentoicrnine tRcgitlnc'. CIBA} has been
`ruggested. However. I gradual drop in blood pressure will usually retult when sufficient
`sedation haa been achieved. Chlorpromazlne antagonizes the central Itlrnulant elrects of
`amphetamines and can he used to treat unnhetatnine intoxication.
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`.
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`We also have the following requeat and acknowlednrnent regarding chemistry and ntnnufcctuting
`controls:
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`I.
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`We request that you place all In validation batches on long-term stability at ambient |i.e.
`either 3o"IantbRH or 25-Womtnltlli conditions. Please provide your stability protocol and
`commitment lie. storage conditions. sampling limes. snd tests to be perforrned).
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`2.
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`As requested. a 24-month expiration dating period at ambient conditions ll lcccptlbie.
`
`There revisions are terms of theuupptement approval. Marketing the product before matting.
`exactly as agreed to. the l'l\'iIltIIII tn the products‘: labeling ma) render the product mtahrcndod
`and an unapproved new drug
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`Amerigen Ex. 1065, p. 3
`Amerigen Ex. 1065, p. 3
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`

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`0 NBA ll-522!S~0ID
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`Pleue Ihtmlt sixteen copies of the FPL II soon as it la available. in no one more than 30
`daya after it is printed or 6 months from the date of this letter. Please lndlvlduelly mount ten
`of the copies on heavy weight paper or similar material. For administrative purposes this
`submlsalon should be designated "FINAL PRINTED LABELING‘ for approved supplemental
`NDA ll-522 I S-010. Approval of this labeling by FDA in I101 required before it is used.
`Should additional information relating to the safety and effectiveness of the drug heeorne
`avsttnble. tunher revision of {hit lsbellng may be required.
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`3
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`We remind you that you must comply with the requirements for an approved NDA set forth
`under 2! CFR 314.30 and 314.81.
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`Should you have my questions. pleneeleonteet Steven D Herdemsn. R..Ph.. Regulatory
`Management omm. It tJonso-1.2m.
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`D
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`Sincerely yours.
`
`(Z qalli/(‘lb
`
`Robert Temple. M.D.
`Director
`
`Office of Drug Evaluation I
`
`Center for Drug Evnluetion and turseereh
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`Amerigen Ex. 1065, p. 4
`Amerigen Ex. 1065, p. 4