US FDA approval for Drug Papaverine capsules given to Taj Pharma
Drug firm Taj Pharmaceuticals Group India today announced tentative approval for Papaverine capsules 150 mg from US Food and Drug Administration.
- (1888PressRelease) October 20, 2011 - Pharmaceuticals Company Taj Pharmaceuticals today received long awaited approval (ANDA) from US health regulator to manufacture and sell Drug Papaverine capsules 150 mg to market in European Market. The Papaverine capsules will be used by the major cardio patents across the globe.
Papaverine is an opium alkaloid used primarily in the treatment of visceral spasm, vasospasm (especially those involving the heart and the brain), and occasionally in the treatment of erectile dysfunction. Papaverine may also be used as a smooth muscle relaxant in microsurgery where it is applied directly to blood vessels and for relieving decreased blood flow to the brain, body due to spasms in blood vessels. It is also used to relieve decreased blood flow to the heart complicated by irregular heartbeat. It works by dilating (widening) blood vessels, which helps increase blood flow and works on the heart to decrease irregular heartbeats.
The FDA approved the drug manufacturing after a long audit and quality confirmations, Taj Pharma will be the first Indian Pharmaceuticals company to manufacture and sell in regulated European Market.
The Papaverine was in FDA Priority review drug for new molecular entity (NME) for over 3 years.
However the company has not clearly announced the Brand or Generic launch in the press conference held at Taj Hotels, Mumbai on 17th October 2011.
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