Indian Cos Get USFDA Nod for 14 First-time Generic Drugs in 2015

Major firms such as Sun Pharma, Dr Reddy\'s Laboratories and Wockhardt faced regulatory issues during 2015.

Published: 15th April 2016 07:05 PM  |   Last Updated: 15th April 2016 07:05 PM   |  A+A-


NEW DELHI: Indian pharma firms accounted for 14 of total 90 first-time generic drug approvals granted by the United States Food and Drug Administration in 2015.

Major domestic firms such as Sun Pharma, Lupin, Glenmark, Aurobindo, Alembic and Hetero Labs figure in the list of first-time generic drug approvals released by the FDA's Office of Generic Drugs.

The approvals include Sun Pharma's Imatinib Mesylate tablets used for treatment of cancer and Lupin's Repaglinde and Metformin Hydrochloride tablets among others.

As per the list, Glenmark received approval for Ezetimibe tablets that are generic of lipid lowering Zetia tablets.

In her message for the Office of Generic Drugs (OGD) Annual Report 2015, Director Kathleen Uhl said: "...2015 marked the highest number of generic drug approvals and tentative approvals ever–more than 700".

OGD's review processes to expedite thorough review of pending abbreviated new drug applications (ANDAs) and cutting the average review time is being streamlined, she added.

"Generic drugs make up nearly 88 per cent of prescriptions filled in the United States and represent affordable access to treatment for many patients and consumers," Uhl said.

However, in 2015 many Indian pharma firms also came under the scanner of the regulator in the US, which remains a key market for Indian generic drug makers.

Major firms such as Sun Pharma, Dr Reddy's Laboratories and Wockhardt faced regulatory issues during 2015.

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