Macleods Pharmaceuticals of Daman, to supply Generic ARV to PEPFAR

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Macleods Pharmaceuticals Limited of Daman, to supply Generic ARV to

PEPFAR

On October 7, 2008, FDA granted tentative approval for a generic

formulation of lamivudine 150 mg and 300 mg tablets, manufactured by

Macleods Pharmaceuticals Limited of Daman, India, indicated for use

in combination with other anti-retroviral drugs for the treatment of

HIV-1 infection.

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

meets 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 outside the United

States under the President's Emergency Plan for AIDS Relief (PEPFAR)

This product is a generic version of Epivir, manufactured by

GlaxoKline, which is still under patent protection.

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. "

http://www.fda.gov/cder/ob/default.htm

This application was reviewed under expedited review provisions

developed by FDA for the PEPFAR program

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

of each manufacturing facility, and of the facilities performing the

bioequivalence studies, to evaluate the ability of the manufacturer

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

bioequivalence data supporting the application prior to granting

approval or tentative approval to these applications.

A list of all Tentatively Approved Antiretrovirals in Association

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

http://www.fda.gov/oia/pepfar.htm

U.S. Food & Drug Administration (FDA)

e-mail: <fda@...>