USA Approves Matrix Laboratories’s fixed-dose combination ARV for Children

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USA Approves Matrix Laboratories's ARV for Children

On January 5, 2011, the Food and Drug Administration (FDA) granted tentative

approval for a fixed-dose combination of lamivudine and zidovudine tablets, 30

mg/60 mg, indicated for use in combination with other antiretrovirals for the

treatment of HIV-1 infection.

The tablets, manufactured by Matrix Laboratories Limited of Hyberdad, India, are

intended for pediatric use, and can be dispersed in liquid for patients unable

to swallow tablets.

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.

As with all generic applications, FDA conducts an on-site inspection of the

manufacturing facilities and of the facilities performing the bioequivalence

studies prior to granting approval or tentative approval to evaluate the ability

of the manufacturer to produce a quality product and to assess the quality of

the bioequivalence data supporting the application.

These products were 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 list of all FDA approved and tentative approved antiretrovirals for PEPFAR can

be found on the FDA web site.

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Searc\

h.DrugDetails