Lupin Ltd has received final approval from the US health regulator for its generic antibiotic minocycline hydrochloride extended-release tablets used for treating acne.
The approval by the US Food and Drug Administration (USFDA) has been granted to the company’s subsidiary, Lupin Pharmaceuticals Inc, for tablets of 65 mg, 80 mg, 105 mg and 115 mg strengths, the company said in a statement today.
The tablets are generic versions of Medicis Pharmaceutical Corporation’s patented drug Solodyn, the company said.
It is an oral antibiotic approved to treat only the red, pus-filled pimples of moderate to severe acne in patients 12 years of age and older, it said.
Citing market research firm IMS’ September 2011 data, the company said Solodyn had sales of $750 million.
Lupin scrips were trading at Rs 467.20 per share, on the BSE, up 0.24 per cent from the previous close.