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ANDA 75-028July 20, 1998Keller and HeckmanAttention: John DubeckU.S. Agent for: Biovail Laboratories, Inc.1001 G Street N.W., Suite 500 WestWashington, DC 20001Dear Sir:This is in reference to your abbreviated new drug applicationdated December 16, 1996, submitted pursuant to Section 505(j) ofthe Federal Food, Drug, and Cosmetic Act, for PentoxifyllineExtended-release Tablets, 400 mg.Reference is also made to your amendments dated October 29, 1997;and February 12, April 9, June 15, June 17, and July 10, 1998.We have completed the review of this abbreviated application andhave concluded that the drug is safe and effective for use asrecommended in the submitted labeling. Accordingly, theapplication is approved. The Division of Bioequivalence hasdetermined your Pentoxifylline Extended-release Tablets, 400 mgto be bioequivalent and, therefore, therapeutically equivalent tothe listed drug (Trental® Tablets, 400 mg, of Hoechst MarionRoussel, Inc.). Your dissolution testing should be incorporatedinto the stability and quality control program using the samemethod proposed in your application.Under 21 CFR 314.70, certain changes in the conditions describedin this abbreviated application require an approved supplementalapplication before the change may be made.Post-marketing reporting requirements for this abbreviatedapplication are set forth in 21 CFR 314.80-81 and 314.98. TheOffice of Generic Drugs should be advised of any change in themarketing status of this drug.We request that you submit, in duplicate, any proposedadvertising or promotional copy which you intend to use in yourinitial advertising or promotional campaigns. Please submit allproposed materials in draft or mock-up form, not final print.
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`Submit both copies together with a copy of the proposed or finalprinted labeling to the Division of Drug Marketing, Advertising,and Communications (HFD-40). Please do not use Form FD-2253(Transmittal of Advertisements and Promotional Labeling for Drugsfor Human Use) for this initial submission.We call your attention to 21 CFR 314.81(b)(3) which requires thatmaterials for any subsequent advertising or promotional campaignbe submitted to our Division of Drug Marketing, Advertising, andCommunications (HFD-40) with a completed Form FD-2253 at the timeof their initial use.Sincerely yours,Douglas L. SpornDirectorOffice of Generic DrugsCenter for Drug Evaluation and Research
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