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Ranbaxy approaches FDA for anti-AIDS drug

Our Bureau

New Delhi , Oct. 29

RANBAXY Laboratories Ltd has filed its first abbreviated new drug approval (ANDA) with the US Food & Drug Administration (FDA) for zidovudine tablets an anti-retroviral drug used for the treatment of AIDS.

This is the first of a series of anti-retroviral (ARV) ANDA filings by the company that are anticipated in the near term that will be supportive of the US President's Emergency Plan for AIDS Relief (PEPFAR) initiative.

According to an official statement, the company will generate and provide appropriate scientific data supporting the efficacy of zidovudine tablets in order to allow the FDA to technically review the formulation and grant final approval. With FDA approval, the formulation can then be employed to manage patients afflicted with AIDS in PEPFAR identified countries, when mutually acceptable procurement terms are agreed upon.

"Ranbaxy's plan is to provide single entity products and fixed dose combination products in the future for FDA approval that can then be employed by PEPFAR to meet the clinical needs of patients," it said.

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