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Aurobindo Pharma Ltd has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Oxymorphone hydrochloride tablets.
The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) product, Opana, of Endo Pharmaceuticals Inc.
The tablets are used to relieve moderate to severe acute pain where the use of an opioid is appropriate. The approved drug has an estimated market size of $55.5 million for the 12 months ending February 2016, according to IMS.
The Hyderabad-based company has also received USFDA approval for Famotidine tablets, which is used to relieve heart-burn associated with acid indigestion and sour stomach. It is bioequivalent and therapeutically equivalent to the RLD Pepcid tablets of McNeil Consumer Pharmaceuticals Co.
The approved drug has an estimated market size of $31 million for the 12 months ending February 2016, according to IMS. The product is expected to be launched in the second quarter of the current financial year, according to a release.
Aurobindo’s scrip gained 0.77 per cent on the Bombay Stock Exchange on Wednesday and was trading at Rs 769.45 by noon.
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