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MYLAN GAINS FIRST GENERIC APPROVAL FOR PINDOLOL TABLETS

Executive Summary

MYLAN GAINS FIRST GENERIC APPROVAL FOR PINDOLOL TABLETS in 5 mg and 10 mg strengths on Aug. 25. Mylan's pindolol is the generic version of the Sandoz brandname product Visken. Sales for the beta blocker last year were approximately $37 mil., Mylan said. Mylan will begin shipping pindolol following FDA approval of its production batches. Those approvals usually take a few weeks. Pindolol is the second product for which Mylan has gained a first generic ANDA approval this year. The pindolol approval brings to seven the number of Mylan generic products cleared by FDA since January. In March, Mylan received tentative approval for the first generic of the top-selling calcium channel blocker diltiazem (Marion Merrell Dow's Cardizem) ("The Pink Sheet" March 23, T&G- 10). Mylan will begin marketing the product after Nov. 5 when MMD's patent for the product expires. Mylan received the second generic approval for a version of Ciba-Geigy's Lopressor (metoprolol) in June. However, the generic firm may not market the beta blocker until Dec. 21, 1993 when the Ciba-Geigy patent expires. In addition, Mylan has gained approval of several other important generic products. At the beginning of the year, Mylan became the fourth company to receive approval for a generic version of ICI's Tenormin (atenolol). Mylan entered the market at the end of July with the second generic approval of piroxicam (Pfizer's Feldene) ("The Pink Sheet" Aug. 10, T&G-10). In May, the company received the second tentative approval for a generic version of Parke-Davis' Lopid (gemfibrozil) ("The Pink Sheet" April 6, p. 4) and full approval for the widely used anti-cancer agent methotrexate.
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