FDA Notifications
Zidovudine injection approved as generic
On April 6, 2010, the FDA granted approval to a generic formulation of zidovudine injection USP, 10 mg/mL, packaged in 200 mg/20 mL single-use vials, manufactured by Pharmaforce, Inc., of Columbus, OH. FDA has determined that the generic formulation is bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Retrovir® IV Infusion, 10 mg/mL, of VIIV Healthcare Co.
Approval of this generic formulation means that it may be marketed in the United States. A list of approved generic formulations of antiretroviral drugs used in the treatment of HIV infection is available at http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118944.htm
Tentative OK for lamivudine, stavudine fixed dose combo
On May 17, 2010, the FDA granted tentative approval for lamivudine and stavudine Fixed Dose Combination tablets, 150mg/30mg, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection in adults. This new fixed dose combination is manufactured by Hetero Drugs Limited, of Hyberdad, India.
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 developed to clarify what regulatory requirements apply to such applications, what issues might be of concern, and how these issues should be addressed. The guidance is intended to encourage sponsors to submit applications for combination and co-packaged products, and to facilitate submission of such applications to FDA.
Generic abacavir sulfate tablets approved
On May 12, 2010, the FDA granted tentative approval for a generic formulation of abacavir sulfate tablets, 300 mg, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
This generic formulation is manufactured by Strides Arcolab Limited, of Bangalore, India, and the application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR).
On April 6, 2010, the FDA granted approval to a generic formulation of zidovudine injection USP, 10 mg/mL, packaged in 200 mg/20 mL single-use vials, manufactured by Pharmaforce, Inc., of Columbus, OH. FDA has determined that the generic formulation is bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Retrovir® IV Infusion, 10 mg/mL, of VIIV Healthcare Co.Subscribe Now for Access
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