Glenmark gets USFDA approval for anti-hypertensive, Trandolapril
20 Jun 2008
Mumbai: Glenmark Pharmaceuticals has received approval from the US Food and Drug Administration (USFDA) for marketing and distribution of its Trandolapril tablets, used in the treatment of high blood pressure.
Glenmark Generics Limited (GGL), a subsidiary of Glenmark Pharmaceuticals Ltd, has received the abbreviated new drug application (ANDA) approval from the USFDA for Trandolapril tablets USP 1 mg, 2 mg and 4 mg and will immediately commence marketing and distribution of these products in the US market, Glenmark said in a release.
Trandolapril is an angiotensin converting enzyme (ACE) inhibitor used to treat high blood pressure and is the generic equivalent of `Mavik' tablets marketed by Abbott Laboratories.
Trandolapril tablets had total sales in excess of $23 million in the twelve months ended March 2008, as per IMS Health.
Along with FDA approvals for Mometasone Cream USP 0.1 per cent, Mometasone Ointment USP 0.1 per cent and Metformin tablets USP 500 mg, 850 mg, 1000 mg, Glenmark now has a portfolio of 33 generic products authorised for distribution in the US market, the release pointed out.
Glenmark currently has over 35 ANDAs filed with the USFDA pending approval, it added.