FDA tentative approvals: generic oral solutions of nevirapine and d4T

In December 2005 the US Food and Drug Administration (FDA) granted tentative approval, through an expedited procedure, to generic versions of the following ARVs:

  • Stavudine for Oral Solution, 1 mg/mL (Aurobindo, India).
  • Nevirapine Oral Suspension, 50 mg/5 mL, (Aurobindo, India).

FDA tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the U.S., it meets all of FDA’s manufacturing quality and clinical safety and efficacy standards required for marketing in the U.S.

As with all generic application assessments, FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications. This is to assess the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

Tentative approval by FDA means that this product will now be available for consideration for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR).

Source: FDA list serve

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