Pharma Block Busters: New US FDA drug Approvals: INDIA
- Good news for the India Pharma Industry:
Glenmark Pharmaceuticals
has recieved FDA's approval for moexipril hydrochloride and hydrochlorothiazide tablets.The tablets are the generic version of Schwarz Pharmaceuticals' Uniretic and are used to treat Hypertension.
This drug has annual sales of $8 million in the US.
----------------------------------------------------------------------------------------------------Another Indian Major, Sun Pharmaceutical Industries recieved the approval for the generic version of Actavis Mid Atlantic's Prometh syrup, used to treat cold, flu and allergies.
---------------------------------------------------------------------------------------------------- Dr. Reddy's Laboratories
has received the US Food and Drug Administration's approval to launch the generic version of Sanofi-Aventis' allergy drug Allegra.The company seems to be the only filer for the drug. It also has first to file rights when the patent for AllegraD24 expires in 2012.
Allegra-D24 Hour is used to treat sneezing, cough, runny or stuffynose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and common cold.
Allegra-D 24 Hour tablets contains: 180 mg fexofenadine hydrochloride for immediate release. 240 mg pseudoephedrine for extended release.
Fexofenadine is anantihistamine that reduces the natural chemical histamine in the body.
India's second-largest drugmaker by sales plans to launch the drug at risk in US by Q1 FY11. The drug has a market size of USD 180 million in the US.
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