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Lupin receives US FDA nod for generic Solodyn tablets
Our Bureau, Mumbai | Friday, December 2, 2011, 16:25 Hrs  [IST]

Pharma major Lupin Ltd has announced that its subsidiary, Lupin Pharmaceuticals Inc. (collectively, Lupin) has received final approval for its minocycline hydrochloride extended release tablets 45 mg, 55 mg, 90 mg and 135 mg strengths as well as tentative approval for its minocycline HCl extended release tablets 65 mg, 80 mg, 105 mg and 115 mg strengths from the US Food and Drug Administration (FDA) for the company's Abbreviated New Drug Application (ANDA) to market a generic version of Medicis Pharmaceutical Corporation's (Medicis) Solodyn (minocycline HCI, USP) extended-release tablets.

Solodyn 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. Medicis's Solodyn (minocycline HCI, USP) extended-release tablets had sales of US$ 750 million as per IMS Sept 2011 data.

Lupin is an innovation led transnational pharmaceutical company producing a wide range of generic and branded formulations and APIs. The company has significant presence in the cardiovascular, diabetology, asthama, paediatrics, CNS, GI, anti-infectives and NSAID space in addition to holding global leadership positions in the anti-TB and cephalosporin segments.

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