Drug maker Wockhardt today said it has received approval from US health regulator to sell generic ropinirole hydrochloride, which is used in the treatment of Parkinson's disease.
The approval by the US Food and Drug Administration (USFDA) is for extended-release tablets in multiple strengths of 2mg, 4mg, 6mg, 8mg and 12mg containing ropinirole hydrochloride, the company said in a statement.
"Wockhardt will launch the product as soon as possible," it added.
Ropinirole's extended release tablet is the generic name for the brand Requip XL, marketed in the US by Glaxo SmithKline, the company said.
Wockhardt will manufacture the extended release tablets of ropinirole at its facility in Aurangabad. The technology for the tablets was developed in-house, it said.
Citing IMS Health data, Wockhardt said the total market for this product in the US is about USD 58 million.
Commenting on the approval, Wockhardt Founder Chairman and Group CEO Habil Khorakiwala said: "This is the sixth US FDA approval for Wockhardt in the past two weeks. Three of these have been for extended-release products".
Wockhardt scrips closed the day at Rs 1,115.20 per share on the BSE, down 7.43% from the previous close.