Aurobindo Pharma secures USFDA nod for Ibandronate Sodium Tablets
Hyderabad-based Aurobindo Pharma Ltd. on Tuesday announced it has received the US Food & Drug Administration (USFDA) approval to manufacture and market Ibandronate Sodium Tablets 150 mg – used in the treatment and prevention of osteoporosis in postmenopausal women. This new product is expected to be launched sometime in April – June 2016-17. “The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Boniva Tablets of Hoffman-La Roche Inc,” Aurobindo Pharma Ltd. said in a statement. Ibandronate Sodium Tablets 150 mg has an estimated market size of 55 million for a period of twelve months ending January 2016. With the approval of this new product, Aurobindo Pharma’s Unit VII formulation facility in Hyderabad has so far received 65 ANDA approvals (including 14 tentative approvals) for developing oral non-antibiotic products. “Aurobindo now has a total of 243 ANDA approvals (208 final approvals including 10 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA,” the company said. Earlier this month, the company had received USFDA approval to manufacture and market Acetylcysteine Injection – used for preventing or lessening hepatic injury after ingestion of acetaminophen. The approved product had an estimated market size of $28 million.
March 15, 2016 | 03:00pm IST