Aurobindo gets final USFDA nod for Metronidazole tablets

Aurobindo Pharma Limited has received final approvals from the US Food and Drug Administration(US FDA) to manufacture and market anti-infective Metronidazole tablets of 250 mg and 500 mg dosages. The company will commence shipping of the product shortly according to a press release issued by Aurobindo.

Metronidazole tablets are used to treat different types of infections which are due to particular types of bacteria and some other infectious organisms, or to prevent infection during an operation. The products has an estimated market size of $ 58 million for the twelve months ending March 2015, the company said citing the IMS data.

According to Aurobindo, this is the 37 th Abbreviated New Drug Application (ANDA) to be approved out of Unit 7 formulation facility in Hyderabad for manufacturing Oral Non-betalactam products. Aurobindo now has a total of 194 ANDA approvals (167 Final approvals including 9 from Aurolife Pharma LLC and 27 Tentative approvals) from USFDA.