Caraco Pharmaceutical Laboratories Ltd has received approval from the US Food and Drug Administration (FDA) to manufacture and market clozapine, a generic form of Novartis' Clozaril, Narendra N. Borkar, Chief Executive Officer, reported.
Clozapine is prescribed for the treatment of schizophrenia and has a US market of about $230 million.
In addition to clozapine, Caraco has received FDA approval for eight generic drugs over the past five quarters. These are: ticlopidine hydrochloride, a generic form of Hoffman LaRoche's Ticlid; meperidine hydrochloride, a generic form of Sanofi-Synthelabo's Demerol; metformin hydrochloride, a generic form of Bristol Myers Squibb's Glucophage; oxaprozin, a generic form of G.D. Searle's Daypro; carbamazepine (chewable), a generic form of Novartis' Tegretol; clonazepam, a generic form of Roche's Klonopin; flurbiprofen, a generic form of Pharmacia's Ansaid; and tramadol hydrochloride, a generic form of R.W. Johnson Pharma Research Institute's Ultram.
Aided by the introduction of new products, the Company last month reported record Q3 and 9-month sales and its first-ever profit for a quarter. As a result, the Company revised upward its sales guidance for 2002 to $21 million, from the earlier-announced $16 to 18 million range.
Borkar said the Company has three drugs pending FDA approval and expects to receive the go-ahead for one of these by yearend. He noted that the Company plans to file one additional drug for FDA approval by year end.