Pharmaceutical Resources Inc (PRI) announced that the FDA granted final approval for flecainide acetate, the generic form of Tambocor. The ANDA was filed by Alphapharm, a subsidiary of Merck KGaA, and Pharmaceutical Resources has exclusive U.S. marketing rights. Alphapharm/PRI were the first to file an ANDA with a Paragraph IV certification and therefore PRI anticipates receiving up to 180 days marketing exclusivity.
Tambocor, marketed by 3M Pharmaceuticals, is indicated for the prevention of paroxysmal supraventricular tachycardias (PSUT), as well as for the prevention of documented ventricular arrhythmia. Annual brand sales are approximately $90 million.
PRI anticipates marketing the product during 2001. Additional updates will be provided on the specific timing of the launch.