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Aurobindo gets FDA approval for pair of new generics

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EAST WINDSOR, N.J. — Aurobindo Pharma Ltd. has received Food and Drug Administration approval for two new generic drug products: amlodipine and olmesartan medoxomil tablets, and glipizide extended-release tablets.

Aurobindo said Monday that its amlodipine and olmesartan medoxomil product comes in dosages of 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg and is a generic version of Azor, a hypertension medication from Daiichi Sankyo Inc.

Amlodipine and olmesartan medoxomil tablets (5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg) totaled U.S. sales of about $255.8 million for the 12 months ended in March, according to IMS Health data reported by Aurobindo.

Aurobindo’s glipizide ER tablets, indicated for the treatment of diabetes, are available in strengths of 2.5 mg, 5 mg and 10 mg and are a generic version of Glucotrol XL tablets from Pfizer Inc.

Glipizide ER tablets had total U.S. sales of approximately $70.3 million for the 12 months through March, Aurobindo said, citing IMS Health market data.


ECRM_06-01-22


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