 "Aurobindo Pharma receives US FDA nod for ulcer and osteoporosis drugs")
The Hydeabad-based Aurobindo Pharma Ltd has received the approval of US Food & Drug Administration (US FDA) for two drugs used for the treatment of ulcer (omeprazole delayed-release capsule) and osteoporosis (ibandronate sodium injection).
US FDA granted final approval for Aurobindo Pharma’s omeprazole delayed-release capsules (in strength of 10 mg, 20 mg and 40 mg), a bioequivalent and therapeutically equivalent to Prilosec capsules of AstraZeneca Pharmaceuticals. According to IMS, omeprazole delayed-release capsules, which are indicated for short-term treatment of active duodenal ulcer in adults, recorded sales of $ 422 million in the US for the twelve months ending June 2015.
Meanwhile, Aurobindo Pharma also received final approvals from the US FDA to manufacture and market ibandronate sodium injection 3mg/3mL (1mg/mL), a generic version of Hoffmann-La Roche’s Boniva injection. Ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women.
US FDA granted final approval for Aurobindo Pharma’s omeprazole delayed-release capsules (in strength of 10 mg, 20 mg and 40 mg), a bioequivalent and therapeutically equivalent to Prilosec capsules of AstraZeneca Pharmaceuticals. According to IMS, omeprazole delayed-release capsules, which are indicated for short-term treatment of active duodenal ulcer in adults, recorded sales of $ 422 million in the US for the twelve months ending June 2015.
Meanwhile, Aurobindo Pharma also received final approvals from the US FDA to manufacture and market ibandronate sodium injection 3mg/3mL (1mg/mL), a generic version of Hoffmann-La Roche’s Boniva injection. Ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women.