Granules India has informed that the US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules India for Methocarbamol Tablet 500 mg and 750 mg. The approved ANDA is the bioequivalent and therapeutically equivalent to Reference Listed Drug (RLD) of Robaxin 500 mg and 750 mg of Auxilium Pharmaceuticals. LLC. Granules India intends to commercialise this product shortly.
The above information is a part of company’s filings submitted to BSE.