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October 30, 2017


Aurobindo Receives FDA Approval for Prasugrel Tablets, 5 mg and 10mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Prasugrel Tablets, 5 mg and 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Prasugrel Tablets, 5 mg and 10 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Effient® […]

October 11, 2017


Aurobindo Receives FDA Approval for Ezetimibe Tablets USP, 10 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Ezetimibe Tablets USP, 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Ezetimibe Tablets USP, 10 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug ZETIA®. Ezetimibe is indicated as […]

October 11, 2017


Aurobindo Receives FDA Approval for Moxifloxacin Ophthalmic Soln. 0.5%.

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Moxifloxacin Ophthalmic Soln. 0.5%. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Moxifloxacin Ophthalmic Soln. 0.5%. to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Vigamox® Moxifloxacin Ophthalmic Solution is indicated as […]

July 19, 2017


Aurobindo Receives FDA Approval for Sevelamer Carbonate Tablets, 800 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Sevelamer Carbonate Tablets, 800 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Sevelamer Carbonate Tablets, 800 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Renvela®. Sevelamer Carbonate is a […]

May 31, 2017


Aurobindo Pharma receives USFDA Approval for Atomoxetine Capsules

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Atomoxetine capsules, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg. Atomoxetine capsules are the AB rated generic equivalent of Eli Lilly and Company’s Strattera […]

May 22, 2017


Aurobindo Receives FDA Approval for Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg to be bioequivalent and, therefore, therapeutically equivalent […]

May 22, 2017


Aurobindo Receives FDA Approval for Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 […]

May 01, 2017


Aurobindo Receives FDA Approval for Olmesartan Medoxomil and Hydrochlorothiazide Tablets

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and […]

May 01, 2017


Aurobindo Receives FDA Approval for Olmesartan Medoxomil Tabs, 5, 20, & 40 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Olmesartan Medoxomil Tablets, 5 mg, 20 mg, and 40 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Olmesartan Medoxomil Tablets, 5 mg, 20 mg, and 40 mg to be bioequivalent and, therefore, therapeutically equivalent […]

February 27, 2017


GPhA changes name to the Association for Accessible Medicines

Its new identity will improve recognition that the generic and biosimilar medicines industry is one of “the nation’s great health care success stories, and that competition from generics and biosimilars lowers the cost of medicine.” WASHINGTON — The Generic Pharmaceutical Association on Tuesday unveiled a new national effort to contain the cost of prescription medicines. […]