Lupin gets US FDA nod for a copy of anti-acne drug Solodyn
Lupin's subsidiary Lupin Pharmaceuticals Inc has received final approval from US Food and Drugs Administration [FDA] for its abbreviated new drug application [ANDA] to market its Minocycline hydrochloride extended-release tablets, a generic version of Medicis Pharmaceutical Corp's Solodyn.
December 02, 2011 / 12:55 IST
Moneycontrol Bureau
Lupin's subsidiary Lupin Pharmaceuticals Inc has received final approval from US Food and Drugs Administration [FDA] for its abbreviated new drug application [ANDA] to market its Minocycline hydrochloride extended-release tablets, a generic version of Medicis Pharmaceutical Corp's Solodyn.Solodyn is an oral antibiotic used to treat red, pus-filled pimples of moderate to severe acne in patients 12 years of age and older.The medicine had sales of USD 750 million for year-ended September 2011, Lupin said citing IMS Health data.Earlier in July this year, Lupin had settled the litigation over Solodyn with Medicis. This settlement meant it could start selling the drug in 45 mg, 90 mg and 135 mg strengths under a license from Medicis from November, Lupin had said then. The settlement also entitles Lupin to start selling Solodyn in other strengths from February 2018 and 2019.Lupin shares were up 1.1% at Rs 470.70 on NSE in morning trade. Discover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!
