`
`ENTER FOR DRUG
`
`EVALUATION AND RESEARCH
`
`Application Number: 020895
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`APPROVAL LETTER
`
`
`
`
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`DRL - EXHIBIT 1032
`0001
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`DRL - EXHIBIT 1032
`
`0001
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`
`
`SERVIC,
`5.0,
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`x?
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`%
`*averg
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`RyLe DEPARTMENTOFHEALTH&HUMANSERVICES
`WEALTHot4,
`
`
`,
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`
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`PublicHealthService
`
`March 27, 1998
`
`Food and Drug Administration
`Rockville MD 20857
`
`NDA 20-895
`
`Pfizer Pharmaceuticals Production Corporation Limited
`c/o Pfizer Central Research
`Attention: Sandra J. Croak-Brossman, Ph.D.
`Eastern Point Road
`Groton, CT 06340
`
`Dear Dr. Croak-Brossman:
`
`Please refer to your September 29, 1997 new drug application (NDA) submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act for Viagra (sildenafil citrate) 25, 50 and
`100 mg Tablets.
`
`We acknowledgereceipt of your submissions dated October 10 and 13, November3 and 14,
`December 3 (two), 5 (three), 16, 18, 19 and 22, 1997; and January 8 and 23,
`February 9 (two) and March 5, 9 and 16, 1998.
`
`The user fee goal date is March 29, 1998.
`
`This new drug application provides for the use of Viagra for the treatment of erectile
`dysfunction.
`
`We have completed the review ofthis application, including the submitted draft labeling, and
`have concluded that adequate information has been presented to demonstratethat the drug
`product is safe and effective for use as recommendedin the enclosed draft. Accordingly, the
`application is approved effective on the date ofthis letter.
`
`The final printed iabeling (FPL) must be identical to the enclosed draft labeling. Marketing the
`product with FPL that is not identical to this draft labeling may render the product misbranded
`and an unapproved new drug.
`
`Please submit 20 copies of the FPL as soon as it is available, in no case more than 30 days after
`it is printed. Please individually mount ten of the copies on heavy-weight paper or similar
`material. For administrative purposes, this submission should be designated "FINAL PRINTED
`LABELING” for approved NDA 20-895. Approval of this submission by FDAis not required
`before the labeling is used.
`
`Should additional information relating to the safety and effectiveness of the drug become
`available, revision of that labeling may be required.
`
`0002
`
`0002
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`
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`Page 2 - NDA 20-895
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`Wehave determined the following dissolution methods and specifications for sildenafil tablets:
`
`In addition, please submit three copies of the introductory promotional material that you
`proposeto usefor this product. All proposed materials should be submitted in draft or mock-up
`form, notfinal print. Please send one copy to the Division of Cardio-Renal Drug Products and
`two copies of both the promotional material and the packageinsert directly to:
`
`Food and Drug Administration
`Division of Drug Marketing, Advertising
`and Communications, HFD-40
`5600 Fishers Lane
`Rockville, Maryland 20857
`
`Validation of the regulatory methods has not been completed. At the present time, it is the policy
`of the Center not to withhold approval because the methods are being validated. Nevertheless,
`we expect your continued cooperation to resolve any problems that may be identified.
`
`Please submit one market package of the drug product whenit is available.
`
`We remind you that you must comply with the requirements for an approved NDAsetforth
`under 21 CFR 314.80 and 314.81.
`
`If you have any questions, please contact:
`
`Mr. Gary Buehler
`Regulatory Health Project Manager
`(301)
`594-5332
`
`Sincerely yours,
`
`Robert Temple, M.D.
`Director
`Office of Drug Evaluation |
`Center for Drug Evaluation and Research
`
`Enclosure
`
`0003
`
`0003
`
`
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