Drug firm Aurobindo Pharma has received final approval from the USFDA to manufacture and market Ibandronate Sodium tablets, used for the treatment and prevention of osteoporosis in women, in the American market.
“The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Ibandronate Sodium Tablets, 150 mg,” Aurobindo Pharma Ltd said in a BSE filing.
The company said this product is expected to be launched in the first quarter of next fiscal.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Boniva Tablets of Hoffman-La Roche Inc, it added.
The approved product has an estimated market size of $55 million for the 12 months ending January 2016 according to IMS, Aurobindo Pharma said.
Ibandronate Sodium Tablets is used in the treatment and prevention of osteoporosis in postmenopausal women.
Aurobindo Pharma currently has a total of 243 ANDA approvals (208 final approvals including 10 from Aurolife Pharma LLC and 35 tentative approvals) from the US.
Stock of Aurobindo Pharma were trading 1.94 per cent lower at Rs 720.85 in morning trade on the BSE.