Aurobindo Pharma gets US drug regulator's nod for two drugs

Aurobindo Pharma said on Saturday that it has received final approvals from US health regulator to sell generic versions of two separate drugs used for treatment of enlarged prostate and bacterial infections in infants.

The company said the US food and drug administration (USFDA) has granted its approval to manufacture and market Tamsulosin Hydrochloride Capsules of strength 0.4mg.

The Tamsulosin Hydrochloride Capsules are generic equivalent of Boehringer Ingelheim Pharmaceuticals' Flomax Capsules, 0.4mg, the company said in a statement.

It is indicated for the treatment of symptoms of an enlarged prostate in men. The market size of the product is estimated to be $244 million for the twelve months ending September 2012 according to IMS, it added.

The other approval is for Clindamycin Palmitate Hydrochloride for oral solution of strength 75mg (base)/5ml. It is the generic equivalent of Pharmacia & Upjohn's patented Cleocin pediatric oral solution and is indicated for indicated in the treatment of serious infections caused by susceptible anaerobic bacteria in infants, the company said.

The market size of the product is estimated to be $57 million for the twelve months ending September 2012 according to IMS, it added.

"The products will be launched soon," the company said, adding it how has a total of 190 abbreviated new drug approvals from USFDA.