💊FDA Confirms ACTIGALL Not Withdrawn, Opens Market for Generics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and Drug Administration (FDA or Agency) has determined that ACTIGALL (ursodiol) capsule, 150 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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 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that COREG CR (carvedilol phosphate) extended-release capsules, 10 milligrams (mg), 20 mg, 40 mg, and 80 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 Notice on Regulatory Review Period Determination for LOQTORZI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LOQTORZI 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 biological product.
Learn More🧪FDA Revokes Emergency Use Authorizations for COVID-19 Tests
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Pfizer Inc. for the Lucira COVID-19 All-In- One Test Kit and Lucira CHECK-IT COVID-19 Test Kit, MAWD Laboratories for the MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR, and Nuclein, LLC (merged with Molecular Diagnostics Inc.) for the DASH SARS-CoV-2/S Test. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Learn More🚫FDA Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Justin Cole Henry for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Henry was convicted of a felony under Federal law for possession with intent to distribute a Schedule III controlled substance. The factual basis supporting Mr. Henry's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Henry was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of February 24, 2025 (30 days after receipt of the notice), Mr. Henry had not responded. Mr. Henry's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Learn More💊U.S. Commerce Determines Dumping Margins on Chinese Capsules
The U.S. Department of Commerce (Commerce) preliminarily determines that hard empty capsules (capsules) from the People's Republic of China (China) are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is April 1, 2024, through September 30, 2024. Interested parties are invited to comment on this preliminary determination.
Learn More💊Preliminary Determination on Hard Empty Capsules from Vietnam
The U.S. Department of Commerce (Commerce) preliminarily determines that hard empty capsules (capsules) from the Socialist Republic of Vietnam (Vietnam) are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is April 1, 2024, through September 30, 2024. Interested parties are invited to comment on this preliminary determination.
Learn More💊FDA Product-Specific Guidances for Bioequivalence Studies
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
Learn More💊Quagen Pharmaceuticals LLC's Application for Controlled Substance Import
Quagen Pharmaceuticals LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn More💊Executive Order on Most-Favored-Nation Drug Pricing Impact
Executive Order 14297 aims to rectify the disparity in pharmaceutical pricing between the U.S. and other developed countries. It emphasizes the need for Americans to access drugs at the most-favored-nation prices and outlines immediate policy actions to address foreign pricing disparities. The order also encourages direct-to-consumer sales at these pricing levels, asserting that U.S. patients should benefit from fair drug pricing relative to global standards.
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