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`EVAL ATI N AND RESEARCH
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`Appligatign Numhgr: 020895
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`APPRQVAL LETTER
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`MYLAN - EXHIBIT 1032
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`MYLAN - EXHIBIT 1032
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`0001
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`Public Health Service
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`March 27, 1998
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`Food and Drug Administration
`Rockville MD 20857
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`NDA 20-895
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`Pfizer Pharmaceuticals Production Corporation Limited
`c/o Pfizer Central Research
`Attention: Sandra J. Croak-Brossman, Ph.D.
`Eastern Point Road
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`Groton, CT 06340
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`Dear Dr. Croak-Brossman:
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`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.
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`We acknowledge receipt of your submissions dated October 10 and 13, November 3 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.
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`The user fee goal date is March 29, 1998.
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`This new drug application provides for the use of Viagra for the treatment of erectile
`dysfunction.
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`We have completed the review of this application, including the submitted draft labeling, and
`have concluded that adequate information has been presented to demonstrate that the drug
`product is safe and effective for use as recommended in the enclosed draft. Accordingly, the
`application is approved effective on the date of this letter.
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`The final printed labeling (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.
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`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 FDA is not required
`before the labeling is used.
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`Should additional information relating to the safety and effectiveness of the drug become
`available, revision of that labeling may be required.
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`Page 2 - NDA 20-895
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`We have determined the following dissolution methods and specifications for sildenafil tablets:
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`In addition, please submit three copies of the introductory promotional material that you
`propose to use for this product. All proposed materials should be submitted in draft or mock-up
`form, not final print. Please send one copy to the Division of Cardio-Renal Drug Products and
`two copies of both the promotional material and the package insert directly to:
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`Food and Drug Administration
`Division of Drug Marketing, Advertising
`and Communications, HFD-40
`5600 Fishers Lane
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`Rockville, Maryland 20857
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`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.
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`Please submit one market package of the drug product when it is available.
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`We remind you that you must comply with the requirements for an approved NDA set forth
`under 21 CFR 314.80 and 314.81.
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`If you have any questions, please contact:
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`Mr. Gary Buehler
`Regulatory Health Project Manager
`(301)
`594-5332
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`Sincerely yours,
`
`Robert Temple, M.D.
`Director
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`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`Enclosure
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