Aurobindo gets approval for tamsulosin hydrochloride capsules and clindamycin palmitate hydrochloride

Aurobindo Pharma has received final approvals from the US Food and Drug Administration (US FDA) to manufacture and market tamsulosin hydrochloride capsules USP 0.4mg (ANDA 202433) and clindamycin palmitate hydrochloride for oral solution USP(Pediatric), 75mg (base)/5mL (ANDA 202409). The products will be launched soon.

Tamsulosin hydrochloride capsules USP 0.4mg is the generic equivalent of Boehringer Ingelheim Pharmaceuticals’ Flomax capsules, 0.4mg and is indicated for the treatment of symptoms of an enlarged prostate (Benign Prostatic Hyperplasia – BPH) in men. The market size of the product is estimated to be $244 million for the twelve months ending September 2012 according to IMS.

Clindamycin palmitate hydrochloride for Oral Solution USP(Pediatric), 75mg (base)/5mL is the generic equivalent of Pharmacia & Upjohn’s Cleocin Pediatric for oral solution, 75mg (base)/5mL and is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria in infants. The market size of the product is estimated to be $57 million for the twelve months ending September 2012 according to IMS.

Aurobindo now has a total of 190 ANDA approvals (163 final approvals including four from Aurolife Pharma and 27 tentative approvals) from US FDA.

EP News Bureau – Mumbai