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Executive Summary

BIOCRAFT GAINS FIRST GENERIC APPROVAL FOR CINOXACIN on Feb. 28, the first generic equivalent of Lilly subsidiary Dista's early quinolone Cinobac. Biocraft Labs received approval for 250 mg and 500 mg capsules of cinoxacin (see chart above). Since the beginning of the year, Biocraft has gained approval for four generic products. The company's generic version of Lederle's Minocin (minocycline) 50 mg and 100 mg capsules was approved on March 3. In February, in addition to cinoxacin, Biocraft received approval for baclofen 10 mg and 20 mg tablets (Ciba-Geigy's Lioresal) and metaproterenol sulfate 10 mg/5 ml syrup (Boehringer Ingelheim's Alupent). Validations for the products should be completed by April, Biocraft said. The end of February approvals were the first for Biocraft in almost two years. The company received its last ANDA approval in March 1990. Biocraft was notified as recently as mid-February by FDA that the company's responses regarding certain good manufacturing practices (GMP) violations were satisfactory. The GMP issues, which related to the manufacture of generic cephalexin at the company's Waldick, N.J. plant, were raised by the agency in an October 1989 regulatory letter. Biocraft said it has revamped its documentation system at the request of FDA. Biocraft said it has applications pending at FDA for 11 products and is planning to file ANDAs for 12 to 15 more. One of the pending applications is for Lilly's Ceclor (cefaclor), which Biocraft has said it hopes to market by the end of 1992 ("The Pink Sheet" April 22, 1991, p. 8). Lilly's patent for the top-selling antibiotic runs out in December 1992; however, Lilly has maintained that an intermediate production step patent will protect the product until December 1994. In all, FDA approved 20 ANDAs for 10 drug products and two bulk antibiotics in February. Included among the approvals are Lemmon's sulindac, Searle's theopylline extended-release 400 mg capsules, Dey Laboratories albuterol sulfate .083% inhalation solution, Novopharm's nifedipine, NMC Laboratories fluocinonide cream and Gencon's GenCept (norethindrone and ethinyl estradiol) tablets. The approval of 20 ANDAs in February is running about average with the approvals coming out of the Office of Generic Drugs in the last few months. In January, 21 ANDAs were approved. The office hit a highwater mark in December 1991, with 23 approvals in one month. As of the end of January, the generic office's backlog of applications was 650, down from 800 at the end of September ("The Pink Sheet" Oct. 14, T&G-9). The number of ANDAs over the statutory 180 day review limit had fallen from 294 to 211 by the end of January.

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