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MYLAN RECEIVES TENTATIVE APPROVAL FOR FIRST GENERIC OF METOPROLOL TARTRATE

Executive Summary

MYLAN RECEIVES TENTATIVE APPROVAL FOR FIRST GENERIC OF METOPROLOL TARTRATE (Ciba-Geigy's Lopressor) on June 29. The generic beta blocker will not be allowed on the market until Dec. 21, 1993 when the Lopressor patent expires. According to FDA's "Orange Book," Ciba-Geigy has two patents for metoprolol tartrate, the first of which expired in April 1991. Schein Pharmaceutical, which received a prospective approval for generic metoprolol tablets in 1989, challenged Ciba-Geigy's 1993 patent in 1986, and Ciba-Geigy followed suit with a patent infringement case against Schein filed in 1987 July 2 that dispute was resolved ("The Pink Sheet" Feb. 20, 1989, T&G-12). Ciba-Geigy said July 2 that the dispute was resolved in its favor, thus the company maintains exclusivity for Lopressor until 1993. Copley Pharmaceuticals received a tentative approval on June 30 for a generic version of Marion Merell Dow's immediate-release Cardizem (diltiazem) in 30, 60, 90 and 120 mg doses. The ANDA for the calcium channel blocker is the company's tenth since November 1991. Following the rush of approvals, the Canton, Mass. firm filed a preliminary prospectus for an initial public offering of 1.9 mil shares at an estimated price of $15 per share ("The Pink Sheet" May 25, p. 7). The IPO has not yet closed. When Cardizem comes off patent in November, Copley's diltiazem will be in at least a three-way generic competition. Mylan Labs received ANDA approval for the four dosage strengths on March 16 ("The Pink Sheet" March 23, T&G-10). MMD quickly followed with a move to capture some of the generic market by making Cardizem available to Rugby under an agreement between a new MMD subsidiary, Blue Ridge Laboratories, and the generic distributor ("The Pink Sheet" April 6, p. 3). Although the date of the Rugby launch has not been disclosed, the company already had begun taking orders in April. Mikart received the first ANDA for a generic version of the second-line tuberculosis treatment, pyrazinamide, which has been marketed by Lederle since 1971. Merck originally launched pyrazinamide in 1955, but Lederle is currently the only manufacturer of the drug. On April 20, FDA approved a supplemental NDA for Lederle's product as an "important component" in the treatment of patients with drug-resistant TB ("The Pink Sheet" June 1, In Brief). version of Fujisaws Lyphomed's Another first generic approval went to Abbott for its version of Fujisawa Lyphomed's Pentam (pentamidine), which lost orphan exclusivity in October 1991. Abbott submitted an ANDA suitability petition to develop the generic version of the injectable drug in February 1990 ("The Pink Sheet" Feb. 12, 1990, In Brief). Able Labs received ANDA approval for its hydrocortisone acetate cream on June 19. According to "The Orange Book," this approval is the first ANDA awarded to Able since 1987, when the company received permission to market clorazepate dipotassium. In March, Able avoided an FDA shutdown of its manufacturing facilities following a trial, during which the company's efforts to correct previously cited violations of current good manufacturing practices regulations were reviewed ("The Pink Sheet" March 30, T&G-3). For the third month in a row, the Office of Generic Drugs' approval output was less than the minimum 20 applications per month targeted by the office. With 19 ANDA approvals during the month of June, (see following chart for complete list of June ANDA approvals), OGD matched the number of ANDAs approved in May, but fell short of the record numbers of generic approvals coming out of the office at the beginning of the year. However, OGD has changed its method of totaling ANDAs and now counts different doses of the same drug as one approval. Using the former way of counting, OGD would have surpassed their goal with 25 approvals.

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