US FDA grants approval for Aurobindo Pharma's metronidazole tablets

Aurobindo Pharma Limited has received final approvals from the US Food & Drug Administration (US FDA) to manufacture and market metronidazole tablets USP 250 mg and 500 mg – a generic equivalent of GD Searle’s Flagyl tablets.
 
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. According to IMS, the product has an estimated market size of $ 58 million for the twelve months ending March 2015.
 
This is the 37th ANDA to be approved out of unit VII 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 US FDA.