Aurobindo gets FDA nod for 2 drugs

Aurobindo gets FDA nod for 2 drugs
Highlights

Aurobindo Pharma on Tuesday said that it had received final approval from the US health regulator for the generic versions of Levetiracetam injection used for treating epilepsy and anti-arthritis drug Celecoxib.

Hyderabad: Aurobindo Pharma on Tuesday said that it had received final approval from the US health regulator for the generic versions of Levetiracetam injection used for treating epilepsy and anti-arthritis drug Celecoxib.

The approval for single-dose vials of Levetiracetam injection from the US Food and Drug Administration (USFDA) is bioequivalent and therapeutically equivalent to the reference listed drug product, Keppra Injection, 500 mg/5 mL (100 mg/mL), of UCB, Inc, the company said.

Levetiracetam injection is used for treatment of partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalised tonic-clonic seizures, it added.

Citing IMS data, the company said the approved product has an estimated market size of $29 million for the twelve months ending November. The company also said it has received final approval from the US health regulator to manufacture and market Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg.

This product is expected to be launched in Q4 FY2016. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Celebrex Capsules of same dosages of GD Searle, it added.

Celecoxib Capsules is used in the treatment of pain and inflammation of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis (2 years and older) ankylosing spondylitis, acute pain in adults, primary dysmenorrhea.

As per IMS data the product has an estimated market size of $976 million for the 12 months ending November 2015. This is the 61st ANDA (including 11 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products, it said.

The company now has a total of 236 ANDA approvals 204 final approvals, including 10 from Aurolife Pharma and 32 tentative approvals, from the USFDA, it said.

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