Lupin gets US nod for hypertension drug
The company's Amlodipine Besylate tablets are AB-rated generic equivalent of Pfizer's Norvasc tablets.
By PTI |
MUMBAI: Pharmaceutical firm Lupin on Tuesday said it has received approval from the US Food and Drug Administration (USFDA) for marketing Amlodipine Besylate tablets, used in treatment of hypertension, in that country.
"We are pleased with the approval of Amlodipine Besylate tablets. This approval broadens our growing portfolio of cardiovascular medications," Lupin Managing Director Kamal Sharma said.
The approval is for Abbreviated New Drug Application (ANDA) of Amlodipine Besylate tablets in strengths of 2.5 mg, 5 mg and 10 mg, Lupin said in a filing to the Bombay Stock Exchange (BSE).
Commercial shipments of the tablets would commence shortly, it added.
The company's Amlodipine Besylate tablets are AB-rated generic equivalent of Pfizer's Norvasc tablets.
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The brand product had annual sales of around 2.7 billion dollar for twelve months ended December 2006, based on IMS Health sales data. Shares of Lupin were trading at Rs 726, up 1.70 per cent on BSE in early morning trade.
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