Glenmark Generics, a subsidiary of Mumbai, India-based Glenmark Pharmaceuticals, has received FDA approval for its abbreviated new drug application (ANDA) to market trandolapril, a generic version of Abbott Laboratories’ blood pressure drug Mavik in 1-, 2- and 4-mg strengths.
The company said it will immediately commence marketing and distribution in the U.S. market.
Trandolapril is an ACE (angiotensin converting enzyme) inhibitor used to treat high blood pressure. Glenmark will join eight other companies in marketing generic Mavik, which had sales of more than $23 million for the 12-month period that ended in March, according to IMS Health.
Earlier this month, Glenmark won approval for a generic version of Bristol-Myers Squibb’s diabetes drug Glucophage (metformin HCl).
Glenmark’s now has 33 generic products authorized for distribution in the U.S. market. The company said it currently has over 35 ANDA’s filed with the U.S. FDA pending approval.