Glenmark Generics is all set to launch Fosinopril Sodium and Hydrochlorothiazide tablets in the US market. Fosinopril Sodium and Hydrochlorothiazide (HCTZ) tablets are available in both 10mg/12.5mg and 20mg/12.5mg strengths, and are indicated for the treatment of hypertension.
The Abbreviated New Drug Application (ANDA) for Fosinopril Sodium and Hydrochlorothiazide tablets, was approved through Glenmark’s longstanding partnership with InvaGen. The company will exclusively market and
distribute the product, while InvaGen will be responsible for their manufacture and supply.
All development, regulatory costs and profits on Fosinopril Sodium and Hydrochlorothiazide tablets’ sale in the US will be shared equally between Glenmark and Invagen.
Terrance Coughlin, CEO of Glenmark Generics, said: “Glenmark is prepared to commence shipping based on today’s final approval from the FDA. As Fosinopril + HCTZ is a maintenance medication, we are very pleased with this approval as it gives us the chance to provide customers with guaranteed and uninterrupted supply which they may not have been getting in the past. We anticipate a successful launch considering the limited competitive landscape coupled with the niche positioning of this product.”