BIOCRAFT KETOPROFEN APPROVAL IS FIRST ORUDIS EQUIVALENT

BIOCRAFT KETOPROFEN APPROVAL IS FIRST ORUDIS EQUIVALENT approved by FDA. Biocraft's ANDA for ketoprofen 25 mg, 50 mg and 75 mg capsules was cleared on Dec. 22. Wyeth-Ayerst markets the nonsteroidal anti-inflammatory drug as Orudis in the U.S. under license from Rhone-Poulenc. The ketoprofen patent expired on Feb. 8, 1991. Biocraft began shipping ketoprofen "immediately" following approval. Wyeth-Ayerst parent American Home Products reported 1991 sales of Orudis of $125 mil., up 38.9% ("The Pink Sheet" April 13, p. 9). AHP is understood to be pursuing an OTC version of the analgesic; Rhone-Poulenc said the ingredient was an OTC candidate at the time of its merger with Rorer. Biocraft also was cleared to market the first generic amoxicillin chewable tablets (equivalent to SmithKline Beecham's Amoxil) on Dec. 22. The two approvals signal the end of the generic firm's recent compliance problems that generated two warning letters during 1992. In a Nov. 5 warning letter, FDA cited Biocraft for "inadequate" standard operating procedures (SOPs) for resampling and retesting blends at its Fairfield and Paterson, N.J. manufacturing facilities ("The Pink Sheet" Nov. 30, T&G-13). Biocraft also received a warning letter March 25 for similar violations ("The Pink Sheet" April 13, T&G-8). The March warning letter ended Biocraft's first string of approvals in two years. Between Feb. 27 and March 2, the company was cleared to market four different drugs ("The Pink Sheet" March 9, T&G-6). The Dec. 22 approvals are Biocraft's first since. Biocraft has begun shipping the chewable amoxicillin tabs. FDA approved the 250 mg strength; a 125 mg tablet is still pending, Biocraft said. While the approvals will help Biocraft end 1992 on a positive note, the company added that "the full financial impact of filling the pipeline will not be felt until next quarter."