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Hyderabad-based Aurobindo Pharma Limited has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Tamsulosin Hydrochloride capsules and Clindamycin Palmitate Hydrochloride for oral solution.
The products will be launched soon, the company stated in a press release.
Tamsulosin Hydrochloride capsules, indicated for the treatment of symptoms of an enlarged prostate in men, are the generic equivalent of Boehringer Ingelheim Pharmaceuticals Flomax capsules. The market size of the product is estimated to be $244 million for the twelve months ending September 2012.
Similarly, Clindamycin Palmitate Hydrochloride for oral solution is the generic equivalent of Pharmacia & Upjohn’s Cleocin pediatric for Oral solution 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.
Aurobindo said that it now has approvals for a total of 190 abbreviated new drug applications from the USFDA.
