FDA: Tenative approval for Descovy and Biktarvy generic drugs
The FDA has granted tentative approval for the generic formulations of Descovy and Biktarvy.
A tentative approval is a notification issued by the Food and Drug Administration (FDA) to drugs that otherwise meet the statutory and regulatory requirements for approval but cannot be approved for marketing in the United States because of patents or exclusivities related to the reference listed drug (RLD) (e.g., brandname drug) upon which they rely. The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) program utilizes drugs that the FDA has tentatively approved to ensure that safe, effective, quality-assured antiretrovirals (ARV), the medicines used to treat and prevent HIV, are available for purchase and distribution under PEPFAR. Many tentatively approved ARV are generic drugs, which are duplicates, except for differences permitted by FDA regulations, of previously FDA-approved drugs. Some tentatively approved ARV are new versions of previously approved ARV, such as new triple fixed combinations as complete regimens, new strengths, or innovative formulations that are specifically designed for children not able to swallow conventional tablets or capsules. An application seeking tentative approval is reviewed by the FDA using the same criteria for safety, efficacy, and quality as any other FDA-approved drug. Tentatively approved drugs, however, cannot be marketed and sold in the United States because their approval is delayed until the FDA issues an approval letter after all patent and exclusivity issues have been resolved and after any necessary additional review of the application. Tentatively approved ARV, however, can still be purchased for use in high prevalence, resource-constrained countries that partner with PEPFAR, the Global Fund or other similar international programs.
Additional information to the following links: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211680
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218766