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Ranbaxy gets FDA nod for Isotretinoin capsules
June 23, 2003 16:15 IST
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.
The company, which is the first to receive FDA for the Isotretinoin capsules of 30 mg, will market it under the name 'Sotret' by its subsidiary Ranbaxy Pharmaceuticals Inc.
The capsules are indicated for recalcitrant nodular acne and the overall sales of the drug stood at $415 million, a company release said in New Delhi.