New Delhi : Aurobindo Pharma said it has received final approval from the US health regulator to manufacture and market generic version of heartburn relief medicine Famotidine tablets.
The approval by the US Food and Drug Administration (USFDA) is for strengths of 10 mg and 20 mg, the company said in a BSE filing.
This product is expected to be launched in the second quarter of 2016-17, it added.
The drug is bio-equivalent and therapeutically equivalent to the reference listed product Pepcid AC Tablets 10 mg and 20 mg of McNeil Consumer Pharmaceuticals Co, it said.
Citing IMS data, the company said that the approved product had an estimated market size of USD 31 million in the 12 month period ended February 2016.
Aurobindo Pharma also received final approval from the USFDA to manufacture and market pain relief drug Oxymorphone Hydrochloride tablets in the strengths of 5 mg and 10 mg.
“The approved ANDA is bio-equivalent and therapeutically equivalent to the reference listed drug product Opana (Oxymorphone Hydrochloride) tablets, 5 mg and 10 mg, of Endo Pharmaceuticals, Inc,” it added.
Oxymorphone Hydrochloride tablets is used to help relieve moderate to severe acute pain where the use of an opioid is appropriate.
The approved product has an estimated market size of USD 55.5 million for the twelve months ending February 2016 according to IMS.
Aurobindo now has a total of 257 ANDA approvals (220 final approvals including 10 from Aurolife Pharma LLC and 37 tentative approvals) from the USFDA.
Shares of the company were trading 0.10 per cent down at Rs 774.65 apiece on BSE.