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.
"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.