FDA grants tentative approval of generic efavirenz
The Food and Drug Administration (FDA) has granted tentative approval for efavirenz capsules, 50 mg, 100 mg, and 200 mg, manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India.
This is a generic version of the already-approved Sustiva capsules, 50 mg, 100 mg, and 200 mg, manufactured by Bristol Myers Squibb Co.
Efavirenz is a member of the class of drugs known as non-nucleoside reverse transcriptase inhibitors, which help keep the AIDS virus from reproducing. This antiretroviral drug is intended to be used in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR).
"Tentative approval" means that the FDA has concluded that a drug product has met all required quality, safety, and efficacy standards, although it may not yet be marketed in the U.S. because of existing patents and/or exclusivity rights. This tentative approval, however, does make the product eligible for consideration for purchase under the PEPFAR program.
The Food and Drug Administration (FDA) has granted tentative approval for efavirenz capsules, 50 mg, 100 mg, and 200 mg, manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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