💊FDA Confirms DECADRON Not Withdrawn for Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that DECADRON (dexamethasone sodium phosphate) solution/ drops, equivalent to (EQ) 0.1 percent phosphate, was not withdrawn from sale for reasons of safety or effectiveness.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 Withdraws Approval of 23 ANDAs from Teva Pharmaceuticals
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 15, 2025. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of February 14, 2025. The document indicated that FDA was withdrawing approval of the ANDA 209325 for miglustat capsule, 100 milligrams, held by Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Suite 201, Berlin, CT 06037. Before FDA withdrew the approval of this ANDA, Breckenridge Pharmaceutical, Inc. informed FDA that they did not want the approval of the ANDA withdrawn. Because Breckenridge Pharmaceutical, Inc., timely requested that approval of ANDA 209325 not be withdrawn, the approval is still in effect. This notice corrects this error.
Learn More💊FDA Withdraws Approval of Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of four abbreviated new drug applications (ANDAs) from multiple 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 Withdraws Approval for ZULRESSO (Brexanolone) Solution
The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for ZULRESSO (brexanolone) solution, 100 milligrams (mg)/20 milliliters (mL), held by Sage Therapeutics, Inc., 55 Cambridge Parkway, Cambridge, MA 02142 (Sage). Sage notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
Learn More💊FDA Determines RIOMET Not Withdrawn, Impacts Drug Approvals
The Food and Drug Administration (FDA or Agency) has determined that RIOMET (metformin hydrochloride) Oral Solution, 500 milligrams (mg)/5 milliliters (mL) has not been 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 Denies Vanda's New Drug Application for HETLIOZ Insomnia Treatment
The Food and Drug Administration (FDA) is announcing the availability of the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) 205677- 012, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for the treatment of insomnia characterized by difficulties with sleep initiation. The decision, which also refuses approval of sNDA 205677-012, is available in the docket identified by the number in the heading of this document.
Learn More💊FDA Proposes Refusal of TRADIPITANT Drug Application
The Director of the Center for Drug Evaluation and Research (Center Director) at the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Vanda Pharmaceuticals, Inc. (Vanda), for TRADIPITANT capsules, 85 milligrams (mg), in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Vanda an opportunity to request a hearing on the matter.
Learn More💊FDA Withdraws Approval of 12 Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 new drug applications (NDAs) from multiple 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 Approves ALYFTREK Under Pediatric Disease Priority Program
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the application for ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor), approved December 20, 2024, meets the criteria for redeeming a priority review voucher.
Learn More📋FDA Guidance on Accelerated Drug Approval and Confirmatory Trials
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway." For drugs granted accelerated approval, sponsors conduct confirmatory studies that must be completed postapproval to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. This draft guidance describes FDA's interpretation of the term "underway" and discusses policies for implementing this requirement, including factors FDA intends to consider when determining whether a confirmatory trial is underway prior to accelerated approval.
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