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FDA ISSUING PROSPECTIVE APPROVAL LETTERS FOR PDST-1962 ANDAs

Executive Summary

FDA ISSUING PROSPECTIVE APPROVAL LETTERS FOR PDST-1962 ANDAs, indicating that approval will be in effect upon the date the original product's patent expires. FDA issued the first such letter to Sidmak Labs Sept. 10, approving the company's ANDA for sulfamethoxazole with trimethoprim. The agency sent Sidmak its prospective approval letter with the belief that the patent on sulfamethoxazole/trimethoprim expires in 1987. "We have completed the review of this abbreviated application and have concluded that the drug is safe and effective for use as recommended in the submitted labeling. Accordingly, the application is approved; however, the effective date of approval is delayed until June 2, 1987, pursuant to 21 U.S.C. 355(j)(4)(B) relating to patent rights," FDA Generic Drug Div. Director Marvin Seife wrote. By giving a prospective approval notice to companies, FDA will be able to continue processing ANDAs in a routine fashion without consideration of whether the original applicant's patent has expired. The agency said such letters will be standard now for products approved before the patent expires. FDA also noted that the Generic Div. "should be advised of any change in the marketing status of this drug. Thus, if circumstances arise which may have impact upon the effective date of approval (e.g., a license agreement between you and the patent holder), you are requested to supplement your application with documentation from the patent holder that a licensing agreement exists and include any relevant conditions or restrictions." Under the ANDA/patent restoration law, a firm must notify both FDA and the original NDA holder if it intends to market a generic version of a drug prior to patent expiration. FDA gave prospective approvals to Sidmak's 400 mg/8O mg and 800 mg/l6O mg sulfamethoxazole and trimethoprim tablets. The combo is marketed by Roche (Bactrim) and Burroughs-Wellcome (Septra), the original NDA holders. (Burroughs-Wellcome developed trimethoprim and Roche obtained rights to sulfamethoxazole from a Japanese firm; the two firms agreed to combine the drugs and submit separate NDAs.) Several generic companies currently market the combo product. The Generic Div. noted that "at or near the effective date of approval," Sidmak should submit "any proposed advertising or promotional copy" in draft or mockup form. The agency said materials for subsequent promotional campaigns should also be submitted at the time of their initial use. (a) Ketchum: 1985 profit is before an extraordinary credit of $102,000 (.09/share), from tax benefit of tax-loss carry-forward. (b) Newport Pharmaceuticals: 1984 sales restated by company. Sales originally $2.6 mil., -19%.

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