Tentative approval of Lamivudine, Nevirapine, and Zidovudine FDC Tablets

USFDA has granted tentative approval for a FDC product containing lamivudine, nevirapine, and zidovudine, 150mg/200mg/300mg, indicated for use alone as a complete regimen, or in combination with other antiretrovirals, for the treatment of HIV-1 infection. This new FDC is manufactured by Strides Arcolab Limited, India. Each constituent ingredient of this generic tablet is currently approved to treat HIV-1 in combination with other antiretroviral agents. The safety and effectiveness of the combination of lamivudine/nevirapine/zidovudine in lowering viral load and increasing CD4+ cells has been demonstrated in previous studies of the individual ingredients used together.

FDA's tentative approval means that although a product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the US, 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. 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. A list of all FDA approvals and tentative approvals for PEPFAR can be found here

Mylan receives tentative approval for Efavirenz tablets

Mylan has received tentative approval from the USFDA for its NDA for Efavirenz Tablets, 50 mg, 100 mg and 200 mg. The approval was secured by the company's subsidiary Matrix Laboratories Limited under the President's Emergency Plan for AIDS Relief (PEPFAR). These innovative paediatric dosages in tablet form were developed by Matrix for use in treating paediatric HIV/AIDS, the company said. Efavirenz is a non-nucleoside reverse transcriptase inhibitor (nNRTI) that has been found to be effective in many combination regimens for the treatment of HIV infection, both in treatment-naive and in treatment-experienced individuals.

Aurobindo receives tentative approval for Perindopril erbumine and Ecitalopram Oxalate

Aurobindo's perindopril erbumine tablets 2mg, 4mg, 8mg and escitalopram oxalate oral solution 5mg (base)/ 5ml have been given tentative approvals by USFDA. Perindopril erbumine tablets are generic of Solvay Pharmaceuticals Aceon tablets and Escitalopram oxalate oral solution are the generic of Forest Laboratories' Lexapro oral solution. Aurobindo now has 85 approved ANDAs from the US FDA (61 final approvals, 24 tentative approvals).