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Aurobindo gets FDA nod for two drugs

Aurobindo gets FDA nod for two drugs
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Aurobindo gets FDA nod for two drugs. City-based Aurobindo Pharma on Monday said it received final approval from the US Food & Drug Administration (USFDA) to manufacture and market two generic drugs - Entacapone tablets and Azithromycin injection. The company will soon launch the two products.

Hyderabad: City-based Aurobindo Pharma on Monday said it received final approval from the US Food & Drug Administration (USFDA) to manufacture and market two generic drugs - Entacapone tablets and Azithromycin injection. The company will soon launch the two products.

Entacapone tablets are generic versions of Comtan Tablets 200mg of Orion Corporation. The tablets are used in the treatment of Parkinson's disease. The drug has an estimated market size of $59 million for the twelve months ending April 2015, Aurobindo Pharma said, citing IMS data.

Azithromycin for Injection USP, 500mg vial is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD), Zithromax 500mg/vial of Pfizer, Inc.

“Azithromycin for injection, USP is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions such as community-acquired pneumonia and pelvic Inflammatory disease,” the company said.

The pharma firm now has 12 ANDAs (represented by 9 product classes) approved out of Unit IV formulation facility in Hyderabad for manufacturing general injectable products and will be marketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC.

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