Lupin gets tentative nod from US FDA for Silodosin Capsules

Pharma Major Lupin’s has received tentative approval for its Silodosin Capsules 4 mg and 8 mg from the United States Food and Drug Administration (US FDA) to market a generic version of Allergan Sales, LLC's Rapaflo Capsules, 4 mg and 8 mg.

The company's Silodosin Capsules, 4 mg and 8 mg are the AB rated generic equivalent of Allergan Sales, LLC's Rapaflo Capsules, 4 mg and 8 mg. It is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. Rapaflo had US sales of $ 228.7 million.

Lupin is a pharmaceutical company and is engaged in formulation of drugs and active pharmaceutical ingredients (APIs), generics, biotechnology, novel drug discovery and development, drug delivery systems and specialty pharmaceuticals.