BIOCRAFT's SECOND GENERIC CEPHALOSPORIN IS CEPHALEXIN (LILLY's KEFLEX)

BIOCRAFT's SECOND GENERIC CEPHALOSPORIN IS CEPHALEXIN (LILLY's KEFLEX), approved by FDA on Feb. 13. Biocraft is the first company to receive a generic cephalexin approval via the ANDA route since the Waxman/Hatch Act went into effect in November 1984. Marketing of cephalexin is delayed until the Lilly patent for Keflex expires on April 22. In a Feb. 17 press release announcing the approval, Biocraft said it "will not manufacture or sell the product until late April" when the Keflex patent expires. The FDA approvals cover cephalexin in 250 and 500 mg capsules as well as cephalexin for oral suspension 125 mg/5 ml and 250 mg/5 ml. Lilly also markets Keflex in tablet form and in pediatric drops. At least one other company, Vitarine, has received FDA approval for a generic cephalexin through an earlier Form 5 or Form 6 application. Vitarine received an original approval for cephalexin 250 and 500 mg capsules in February 1979. The company recently received supplement approvals covering color changes. The cephalexin approval follows by a month Biocraft's approval and launch of generic cephradine (Squibb's Velosef and SmithKline's Anspor). Biocraft's cephradine, the first generic form of the drug to reach the market, was approved Jan. 9 by FDA and introduced Jan. 12. At that time, Biocraft noted that the cephradine approval coincided with FDA's certification of Biocraft's 50,000 square foot cephalosporin manufacturing facility in Fairfield, N.J. The January start-up of the cephalosporin plant met the company's initial projections for completion of the new facility; last spring Biocraft announced that the new plant would be onstream by the second half of the company's fiscal year ended March 31, 1987.