Metronidazole tablets are used to treat different types of infections
Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Metronidazole tablets USP 250mg and 500mg (ANDA 203974). Aurobindo will commence shipping shortly.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Flagyl tablets, 250mg and 500mg of GD Searle.
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 product has an estimated market size of $58 million for the twelve months ending March 2015 according to IMS. This is the 37th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing oral non-betalactam products. Aurobindo now has a total of 194 ANDA approvals (167 Final approvals including nine from Aurolife Pharma and 27 tentative approvals) from US FDA.