Strides Shasun receives USFDA approval for Dutasteride Softgel Capsule
23 November 2015 | News | By BioSpectrum Bureau
Strides Shasun receives USFDA approval for Dutasteride Softgel Capsule
(Photo Courtesy: www.trackregulatory.blogspot.com)
The product is ready for Day 1 launch, said Strides in a press release.
Dutasteride is used to treat benign prostatic hyperplasia (BPH; enlargement of the prostate gland).
The product has gone off patent on November 20, 2015, and Strides Shasun is amongst the first wave of generic players to receive this approval.
The capsule is used to treat symptoms of BPH and may reduce the chance of developing acute urinary retention (sudden inability to urinate).
The product may also decrease the chance that prostate surgery will be needed.
The product will be manufactured at the company's oral dosage facility at Bangalore, and marketed by Strides Shasun in the US Market.
According to IMS data, the US market for Dutasteride Capsules is approximately US $470 Million.
