New Delhi : Drug firm Lupin has received tentative approval from the US health regulator for generic Silodosin capsules used for treatment of non-cancerous enlargement of the prostate gland.
The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market its generic Silodosin capsules in the strengths of 4 mg and 8 mg in the US, Lupin said in a filing to BSE.
The company’s product is the generic version of Allergan Sales LLC’s Rapaflo capsules in the same strengths, it added.
“Rapaflo had US sales of USD 228.7 million according to IMS MAT June 2016,” Lupin said.
The capsules are used for the treatment of the signs and symptoms of benign prostatic hyperplasia, it added.