US FDA grants Tentative Approval for Emcure's generic version of Combivir

[Guest guest]

US FDA grants Tentative Approval for Emcure's generic version of Combivir

FDA granted tentative approval on August 8, 2007 for a generic formulation of a

combination product, lamuvidine and zidovidine tablets, 150 mg/300 mg,

manufactured by Emcure Pharmaceuticals Inc. of Pune, India, under expedited

review provisions developed 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, even though it may not yet

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

However, tentative approval does make the product eligible for consideration for

purchase under the PEPFAR program.As with all generic applications, FDA conducts

on-site inspections of each manufacturing facility 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.

This is a generic formulation of FDA approved Combivir Tablets, 150 mg/300 mg,

marketed by GlaxoKline, which is subject to patent and pediatric

exclusivity protections.Effective patent dates and additional marketing

exclusivities can be found in the agency's publication titled Approved Drug

Products with Therapeutic Equivalence Evaluations, also known as the " Orange

Book " Lamuvidine and zidovidine are both Nucleoside Reverse Transcriptase

Inhibitors (NRTI) indicated for used in combination with other antiretroviral

agents in the treatment of HIV infection.

KleinOffice of Special Health IssuesFood and Drug Administration

StrubleDivision of Antiviral Drug ProductsFood and Drug Administration

An archive of past list serve announcements is available on the FDA web site at

http://www.fda.gov/oashi/aids/listserve/archive.html

Kumara Singaravelu, MBBS, MPH

School of Public Health

State University of New York at Albany

Rensselaer, NY

e-mail: <kcvel@...>