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Ranbaxy Laboratories, which has been facing regulatory hurdles in the US, has been allowed to sell generic Valsartan tablets used for treating high blood pressure and heart failure in the American market.
Ohm Laboratories Inc, a wholly-owned subsidiary of the company has received approval from the US Food and Drug Administration to manufacture and market generic Valsartan tablets with 180 days of marketing exclusivity, Ranbaxy Laboratories Ltd said in a statement.
The approval is for Valsartan tablets in the strengths of 40 mg, 80 mg, 160 mg, and 320 mg, it added.
The patent for Valsartan had expired in 2012 and the launch of the company's generic version has been pending since.
The USFDA had clamped down on the company for manufacturing norms violations and banned import of drugs produced at the Ranbaxy's four plants in India.
In May last year, Ranbaxy pleaded guilty to 'felony charges' related to the manufacture and distribution of certain 'adulterated' drugs made at the Dewas and Paonta Sahib units and agreed to pay $500 million to US authorities as penalty.
Commenting on the approval for Valsartan, Ranbaxy USA North America Sales and Distribution Vice President Bill Winter said the first-to-file FDA approval for Valsartan tablets will be introduced to all classes of trade, with 180- days marketing exclusivity, "as soon as sufficient supplies are manufactured to meet the needs of the market".
Valsartan will be manufactured at the Ohm facilities located in New Brunswick, New Jersey, he added.
The product is generic version of pharma major Novartis' patented drug Diovan.
"For the U S healthcare system, Valsartan adds to the growing portfolio of generic medications which have played such an integral role in helping to alleviate the burdens of rising costs of treatment," Winter said.
Total annual market sales for Diovan were at $2.19 billion as per IMS - MAT: April 2014, the company said.
Shares of Ranbaxy Laboratories were today trading at Rs 497.60 per scrip in the morning trade on BSE, up 5.48 per cent from it's previous close.
