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Tuesday, Nov 04, 2003

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Dr Reddy's gets FDA nod for new drug application

Our Bureau

Hyderabad , Nov. 3

DR Reddy's Laboratories Ltd, the Hyderabad-based pharmaceutical major listed on the New York Stock Exchange (NYSE), has received the final approval of the United States Food and Drug Administration (USFDA) for AmVaz (Amlodipine Maleate).

With this, the company has become the first Indian pharmaceutical company to receive FDA approval for a new drug application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetics Act.

Commenting on the development, Dr Reddy's Chief Executive Officer, Mr G.V. Prasad, said, "the final approval, the first for an Indian pharmaceutical company, marks a significant milestone for Dr Reddy's, setting the stage for the launch of our first specialty branded product in the US."

Stating that the company has not yet made a final decision on the launch date, he said, "But we are making all necessary preparations for the launch and are in the process of finalising a co-promotion partner for AmVaz (Amlodipine Maleate) in the US."

Preparations were on to launch Amlodipine Maleate in Europe upon expiration of the Supplementary Protection Certificate in March 2004.

The company said its US product pipeline currently comprises 27 abbreviated NDAs (ANDAs), 2 NDAs (including Amlodipine Maleate) and 44 drug master files (DMFs). Of these ANDAs, 20 were submitted under Paragraph IV. During the current fiscal, the company expects to file 15-18 ANDAs, 15 DMFs and additional NDAs.

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