Aurobindo gets FDA nod for 2 drugs

Highlights

Pharma major Aurobindo Pharma Limited on Wednesday said it had received final approval from the USFDA to manufacture and market Eptifibatide injection and Levonorgestrel tablet.

Hyderabad: Pharma major Aurobindo Pharma Limited on Wednesday said it had received final approval from the USFDA to manufacture and market Eptifibatide injection and Levonorgestrel tablet.

Eptifibatide injection is used in the treatment of acute coronary syndrome. It is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Integrilin Injection, 20 mg/10 mL, 75 mg/100 mL, and 200 mg/100 mL of Schering Corporation, Aurobindo said.

The product has an estimated market size of $137 million for the twelve months ending October 2015 according to the company. This product is expected to be launched in this month.

Levonorgestrel tablet is an oral contraceptive used for prevention of pregnancy. It has an estimated market size of $64 million for the twelve months ending October 2015. The drug is therapeutically equivalent to Plan B One-Step tablet of Teva Branded Pharmaceutical Products R&D, Inc.

With these, Aurobindo now has a total of 222 ANDA approvals. Of them, 194 final approvals, including 10 from Aurolife Pharma LLC, and 28 tentative approvals from the US health regulators.

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