Glenmark arm launches Fosinopril Sodium and Hydrochlorothiazide tablets in US

Glenmark arm launches Fosinopril Sodium and Hydrochlorothiazide tablets in USGlenmark Generics Inc., USA (GGI), the US subsidiary of Glenmark Pharmaceuticals, has finally initiated the launch of Fosinopril Sodium and Hydrochlorothiazide tablets in the U.S. market.

The company stated in a communiqué that Fosinopril Sodium and Hydrochlorothiazide (HCTZ) tablets are available in both 10mg/12.5mg and 20mg strengths and are indicated for the treatment of hypertension.

It should be noted that Glenmark’s product is the AB rated therapeutic equivalent of Bristol Myers Squibb’s Monopril-HCT.

According to IMS Health Data, the overall generic market sale for the product is approximately USD 10 million for the 12 months period ending March 2009.

The Abbreviated New Drug Application (ANDA) for Fosinopril Sodium and Hydrocholorothiazide tablets was approved through Glenmark’s longstanding partnership with InvaGen Pharmaceuticals Inc.

The latest approval expands Glenmark’s portfolio to 46 generic products authorized for distribution in the US market.

Till date, the company has over 40 ANDAs pending approval with the U.S.FDA.