US FDA has granted its approval to Wockhardt Ltd for marketing a generic version of 2mg, 4mg, 6mg, 8mg & 12mg extended-release tablets containing Ropinirole hydrochloride, used in the treatment of Parkinson's disease. Ropinirole extended release tablet is the generic name for the brand Requip XL, marketed in the US by Glaxo SmithKline. Wockhardt has announced that it will launch the product very soon.
According to IMS Health, the total market for this product in the US is about $58 million and the incidence of Parkinson's disease has been increasing worldwide.
Advertisement"This is the sixth US FDA approval for Wockhardt in the past 2 weeks," said Dr. Habil Khorakiwala, Wockhardt Founder Chairman & Group CEO. "Three of these have been for extended-release products. This continues to demonstrate Wockhardt's capability in developing technologically challenging products" he further added.
Wockhardt will be manufacturing the extended release tablets of Ropinirole at its facility in Aurangabad, India. The technology for the tablets was developed in-house.
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