Lupin receives tentative USFDA approval for Niacin oral tablets: Report

02 Jan 2014 Evaluate

Lupin has reportedly received tentative US Food & Drug Administration (USFDA) approval to sell Niacin oral tablets of strength 500 mg, 750 mg and 1000 mg in the US market. The company has semi-exclusivity for the said drug and will launch the drug after getting final approval from the USFDA. The drug Niacin is used in treatment of cardiovascular diseases as it increases HDL cholesterol levels.

Earlier on December 18, 2013, the company’s US subsidiary-Lupin Pharmaceuticals Inc had launched Abacavir Sulfate, Lamivudine, and Zidovudine Tablets, 300mg (base) / 150mg / 300mg in the US after the US District Court for the District of Delaware ruled that the Lupin’s generic version of Trizivir did not infringe on patents.

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs globally.

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