02

Feb 2018

Aurobindo Receives FDA Approval for Niacin Extended-Release Tablets USP

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Niacin Extended-Release Tablets USP, 500 mg, 750 mg, and 1000 mg. Aurobindo’s Niacin Extended-Release Tablets USP are an AB-rated generic equivalent to the reference listed drug NIASPAN®. Niacin Extended-Release tablets... Read more

26

Jan 2018

Aurobindo Receives FDA Approval for Tenofovir Disoproxil Fumarate Tablets

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mg, and 300 mg. Aurobindo’s Tenofovir Disoproxil Fumarate Tablets are an AB-rated generic equivalent to the reference listed drug VIREAD®. Tenofovir... Read more

03

Jan 2018

Aurobindo Receives FDA Approval for Lorazepam Tablets USP

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Lorazepam Tablets USP, 0.5 mg, 1 mg, and 2 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Lorazepam Tablets USP to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Ativan®. Lorazepam... Read more

03

Jan 2018

Aurobindo Receives FDA Approval for Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 5 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/12.5 mg, 10 mg/160 mg/25 mg, and 10 mg/320 mg/25 mg. Aurobindo’s Amlodipine, Valsartan... Read more

02

Jan 2018

Aurobindo Pharma USA receives the Community Enhancement Award from East Windsor Township!

It is an East Windsor Township tradition to recognize businesses – how important they are to the community, how proud the township is of them and how they contribute to the community – every year, Mayor Janice Mironov said There are three awards – the Business Beautification Award, the Community Service Award and the Community... Read more

15

Dec 2017

Aurobindo aims at cancer as it climbs the value chain

Developing and filing for both small-molecule and biological cancer therapies forms a key part of Aurobindo’s strategy to target higher-value products. Aidan Fry examines the company’s plan in this Generic’s bulletin Dec 2017 article.... Read more

01

Dec 2017

Aurobindo Receives FDA Approval for Quetiapine Fumarate Extended Release Tablets.

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300mg and 400mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Quetiapine Fumarate Extended-Release Tablets 50 mg, 150 mg, 200 mg, 300 mg, and 400... Read more

30

Oct 2017

Aurobindo wins Company of the Year, Asia-Pacific Award at the Global Generics & Biosimilars Awards 2017

Frankfurt, 24 October 2017 – Aurobindo Pharma Limited and Generics Bulletin are pleased to announce that Aurobindo has won the Company of the Year, Asia-Pacific Award at the Global Generics & Biosimilars Awards 2017, organized by Generics Bulletin. The Company of the Year, Asia-Pacific Award was sponsored by Eva Pharma and judged by an expert panel. “Congratulations... Read more

30

Oct 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®... Read more

11

Oct 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... Read more