Hetero Drugs Limited recevies US FDA approval fixed dose combination ARV tablets

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Indian Pharma co recevies tentiative US FDA approval of lamivudine, nevirapine,

and stavudine fixed dose combination tablets

On September 10, 2010, the Food and Drug Administration granted tentative

approval for a fixed dose combination formulation of lamivudine, nevirapine, and

stavudine tablets, 150 mg/200 mg/30 mg indicated for use alone as a complete

regimen or in combination with other antiretrovirals for the treatment of HIV-1

infection.

This fixed-dose combination is manufactured by Hetero Drugs Limited of Hyberdad,

India

FDA's tentative approval means that although a product meets all of the safety,

efficacy, and manufacturing quality standards required for marketing in the

U.S., existing patents and/or proprietary issues currently prevent marketing of

the product in the United States.

Tentative approval, however, does qualify the product for consideration for

purchase under the President's Emergency Plan for AIDS Relief, or PEPFAR

program.

This Fixed Dose Combination product was reviewed for PEPFAR under the FDA

guidance titled Fixed Dose Combinations, Co-Packaged Drug Products, and

Single-Entity Versions of Previously approved Antiretrovirals for the Treatment

of HIV developed to clarify what regulatory requirements apply to such

applications, what issues might be of concern, and how these issues should be

addressed.

The guidance is intended to encourage sponsors to submit applications for

combination and co-packaged products, and to facilitate submission of such

applications to FDA.

A complete list of all Approved and Tentatively Approved Antiretrovirals in

Association with the President's Emergency Plan is available on the FDA web

site.