Tentative US FDA approval for Hetero Drugs Hyberdad for generic stavudine and efavirenz

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Tentative approvals of generic stavudine and efavirenz

On February 29, 2008, FDA granted tentative approval for two generic

formulations of drugs used to treat HIV/AIDS. Stavudine capsules, 15 mg, 20 mg,

30 mg, and 40 mg., and efavirenz tablets, 600 mg, all manufactured by Hetero

Drugs Limited, Hyberdad, India, were tentatively approved for use in combination

with other antiretrovirals in the treatment of HIV infection.

The applications were reviewed under expedited review provisions for the

President’s Emergency Plan for AIDS Relief (PEPFAR)

" Tentative approval " means that FDA has concluded that a drug product has met

all required quality, safety and efficacy standards, but is not eligible for

marketing in the U.S. because of existing patents and/or exclusivity rights.

Tentative approval, however, does make the product eligible for consideration

for purchase under the PEPFAR program.

Effective patent dates can be found in the agency's publication titled Approved

Drug Products with Therapeutic Equivalence Evaluations, also known as the

" Orange Book "

These tentative approvals are generic versions of Zerit (stavudine) capsules, a

Nucleoside Reverse Transcriptase Inhibitor (NRTI), 15 mg, 20 mg, 30 mg, and 40

mg, and Sustiva (efavirenz) tablets, a Nonnucleoside Reverse Transcriptase

Inhibitor (NNRTI), 600 mg. Both Zerit and Sustiva are products of Bristol Myers

Squibb.

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

manufacturing facility and of the facilities performing the bioequivalence

studies prior to granting approval or tentative approval to these applications

to evaluate the ability of the manufacturer to produce a quality product and to

assess the quality of the bioequivalence data supporting the application.

A list of all Approved and Tentatively Approved Antiretrovirals in Association

with the President's Emergency Plan (PEPFAR) is available on the FDA website.

Klein

Office of Special Health Issues

Food and Drug Administration

Struble

Division of Antiviral Drug Products

Food and Drug Administration

U.S. Food & Drug Administration (FDA)

e-mail: <fda@...>