Caraco Pharmaceutical Laboratories Ltd. has received approval from the US Food and Drug Administration (FDA) to manufacture and market digoxin, a generic form of Glaxo Wellcome's Lanoxin, Narendra N. Borkar, chief executive officer, announced.
Digoxin is prescribed for the treatment of mild to moderate cardiac failure and has a US market of about $155 million. Caraco will produce digoxin in two strengths, 0.125 mgm and 0.25 mgm.
In addition to digoxin, Caraco has received FDA approval for nine generic drugs over the past six quarters. These are: clozapine, a generic form of Novartis' Clozaril; 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.
Borkar said the Company has three additional drugs pending FDA approval and expects to receive approval for these by yearend. He noted that the Company plans to file four new generic-drug applications with the FDA this year.
Caraco has an extensive R&D Center at its Detroit headquarters complex and receives R&D support from Sun Pharmaceutical Industries Ltd., India's fifth largest pharmaceutical firm.