Ranbaxy Laboratories on Monday said it has received the US Food and Drug Administration's approval to manufacture and market Isotretinoin capsules, a generic version of Hoffman LaRoche's Accutane.
In 2009, Ranbaxy had to recall about 4,000 cartons of Sotret Isotretinoin through its US-based subsidiary.
Ranbaxy, its partners and Actavis have signed a non-exclusive agreement.
While Ranbaxy tested the lot in question and found it to have met the specified standards, it is recalling the product on the US health regulator Food and Drug Administration's recommendation, the company said.
India's leading drug maker Ranbaxy has initiated a voluntary recall of 4,348 cartons of its skin infection drug Sotret (isotretinoin) in the United States. The entire lot pertains to a single batch of tablets which were found to be 'out of specification'.This is the second instance in four months when Ranbaxy has initiated a recall. In July, the company had pulled out a lot of Sotret from the US market after it was found to be degraded.
Analysts are eyeing bigger launches that will positively impact company's fortunes.
Markets across the globe are rallying on hopes that the US Federal Reserve won't lift interest rates until 2016.
