💊FDA Confirms ACTIGALL Not Withdrawn, Opens Market for Generics
The Food and Drug Administration (FDA or Agency) has determined that ACTIGALL (ursodiol) capsule, 150 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ursodiol capsule, 150 mg, if all other legal and regulatory requirements are met.
Learn More💊FDA Draft Guidance on Fluticasone Propionate Impacting Generic Drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Fluticasone Propionate." The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fluticasone propionate nasal spray, metered.
Learn More💊FDA Announces Public Meeting on Generic Drug User Fee Reauthorization
The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 to 2032. At the end of September 2027, new legislation will be required for FDA to continue to collect generic drug user fees for future FYs. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization; hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (i.e., the GDUFA III Commitment Letter) (https://www.fda.gov/industry/ generic-drug-user-fee-amendments/gdufa-iii-reauthorization); provide a period of 30 days after the public meeting to obtain written comments from the public; and publish the comments on FDA's website. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program cycle. These comments will be published and available on FDA's website.
Learn More💊FDA's Generic Drug User Fee Program Information Collection Overview
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More💊FDA Decision on MOBIC Allows Continued Generic Approvals
The Food and Drug Administration (FDA or Agency) has determined that MOBIC (meloxicam) tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Learn More💊FDA Confirms FLUMADINE Not Withdrawn for Safety or Effectiveness
The Food and Drug Administration (FDA, the Agency, or we) has determined that FLUMADINE (rimantadine hydrochloride) tablet, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Learn More📄FDA Notice
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with our generic drug user fee program.
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