Mumbai: Drug maker Glenmark Pharmaceuticals said on 20 June it has received approval from the US Food and Drug Administration (US FDA) for marketing and distribution of Trandolapril tablets, used in the treatment of high blood pressure.
Glenmark Generics Ltd (GGL), a subsidiary of Glenmark Pharmaceuticals, has received Abbreviated New Drug Application (ANDA) approval for tablets in the strengths of 1 mg, 2 mg and 4 mg, the company informed the Bombay Stock Exchange.
Glenmark would immediately commence marketing and distributing these products in the US market, the company added.
Trandolapril is an ACE (Angiotensin Converting Enzyme) inhibitor used to treat high blood pressure and is the generic equivalent of Mavik tablets marketed by Abbott Laboratories.
The total sales for Trandolapril tablets in the twelve month period ending March 2008 were over $23 million, as per IMS Health.
This recent approval coupled with the three ANDA approvals received from the US FDA in May 2008 for Mometasone Cream, Mometasone Ointment and Metformin Tablets brings GGLs current portfolio to 33 generic products authorized for distribution in the US market.
Glenmark currently has over 35 ANDAs filed with the US FDA pending approval.