💊FDA Determines Regulatory Review Period for LIVDELZI Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LIVDELZI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human drug product.
Learn More💊FDA Notice on Patent Extension for EXEM FOAM
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EXEM FOAM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Learn More💊FDA's Determination of Regulatory Review Period for RIVFLOZA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RIVFLOZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Learn More📋FDA Releases Guidance on Raw Data Submission for Animal Drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #287 entitled "Raw Data for Safety and Effectiveness Studies." This guidance provides information to animal drug sponsors (sponsors) on the use of raw data in the Center for Veterinary Medicine's (CVM) review of safety and effectiveness studies submitted in support of new animal drug applications. This guidance also describes our recommendations for submitting raw data.
Learn More💊FDA Determination on Epinephrine Supports Generic Drug Approvals
The Food and Drug Administration (FDA or Agency) has determined that EPINEPHRINE (epinephrine) solution, 1 milligram (mg)/ milliliter (mL), prefilled syringe for intravenous use, was not withdrawn from sale for reasons of safety or effectiveness.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 Draft Guidance on Bioequivalence for Immediate-Release Dosages
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is the second in the ICH M13 series of guidances and describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment for additional strengths of orally administered immediate-release (IR) solid oral dosage forms (i.e., tablets, capsules, and granules/powders for oral suspension), including considerations for biowaivers. The intent of this draft guidance is to provide harmonized criteria and data that support waivers for drug applications with multiple strengths when in vivo BE has been demonstrated for at least one strength using the principles outlined in the final guidance "M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms" published in October 2024.
Learn More💊FDA Determination on COREG CR Drug Approval and Implications
The Food and Drug Administration (FDA, Agency, or we) has determined that COREG CR (carvedilol phosphate) extended-release capsules, 10 milligrams (mg), 20 mg, 40 mg, and 80 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 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 Withdraws Approval of Two Drug Applications - Business Implications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of two new drug applications (NDAs) from two applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Learn More💊FDA Revokes Emergency Use Authorizations for Specific Drug Products
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Fresenius Medical Care North America (Fresenius) for multiFiltrate PRO System and multiBic/multiPlus solutions (EUA 048), and to Baxter Healthcare Corp. (Baxter) for REGIOCIT (EUA 068). FDA revoked the Authorizations on January 16, 2025, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, including an explanation of the reasons for the revocations, are reprinted in this document.
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