Aurobindo Pharma has got final approval from the US drug regulator to manufacture and market a generic version of Tamsulosin Hydrochloride capsules used to treat symptoms of enlarged prostate in men. It has also received approval to sell a copy of Clindamycin Palmitate Hydrochloride for oral solution used in bacterial infections in infants.
Aurobindo Pharma on Saturday said it has received final approval from the US Food and Drugs Administration to manufacture and market Tamsulosin Hydrochloride capsules in 0.4mg strength.
The drug is a generic version of Boehringer Ingelheim Pharmaceuticals' Flomax capsules and is indicated for the treatment of symptoms of an enlarged prostate in men.
The US market size of the product was around USD 244 million for the 12-months ended September 2012, Aurobindo said, citing IMS Health data.
Further, Aurobindo Pharma has also got final approval from US FDA to manufacture and market Clindamycin Palmitate Hydrochloride for oral solution in pediatric, 75mg (base)/5 ml strength.
Clindamycin Palmitate is a copy of Pharmacia & Upjohn's Cleocin and is indicated for treating serious infections caused by susceptible anaerobic bacteria in infants.
For 12-months ended September 2012, the US market size of the drug was around USD 57 million, the company said citing IMS Health data.
The Hyderabad headquartered company now has 190 ANDA approvals from the US drug regulator. These include 163 final and 27 tentative approvals.
Aurobindo Pharma shares closed at Rs 196.65 on NSE on Friday, down 1.4 percent.