For Immediate Release: October 31, 2025 The U.S. Food and Drug Administration today announced actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children. The FDA sent notices to four companies outlining the …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
FDA recommends that ingestible fluoride drug products be limited to children aged three years and older who are at high risk for tooth decay. Read FDA's assessment of the benefit/risk considerations regarding the use of ingestible fluoride drug …
Moonlight Yellow Peaches Individual pieces 4401 4044 P1 01PCLC, 03PCAF, 106PCLF, 113PCAF, 113PCLF, 129PCLF, 134PCLF, 142PCLF, 150PCLF, 151PCLF, 159PCABA, 159PCABB, 159PCPG10, 20, 22PCAB, 22PCPG10A, 22PCPG10B, 22PCP8A, 22PCPG8B, 22PCPG8C, 23, 25, 30PCEN …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Docket Number: FDA-2011-D-0605 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of New Drugs, Office of Therapeutic Biologics and Biosimilars FDA is posting this document to provide advance notice to the public. After the …
On This Page Date: November 6, 2025 Time: 9:00 a.m. - 3:00 p.m. ET Location: Event Location FDA Headquarters FDA White Oak Campus 10903 New Hampshire Ave, Building 31 The Great Room Silver Spring, MD 20903 United States The 17th Annual Sentinel Initiative …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
On This Page Date: November 6, 2025 Time: 9:00 a.m. - 3:00 p.m. ET Location: Event Location FDA Headquarters FDA White Oak Campus 10903 New Hampshire Ave, Building 31 The Great Room Silver Spring, MD 20903 United States The 17th Annual Sentinel Initiative …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Delivery Method: Via Electronic Mail - Delivery and Read Receipt Requested Reference #: 320-26-07 Product: Drugs Recipient: Recipient Name Mr. Robert Kibbe Recipient Title President and CEO The Tranzonic Companies/Innocore Sales & Marketing Inc. 26301 …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
On October 24, 2025, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
76 218492 Prucalopride Tablets Novitium Pharma LLC Motegrity Tablets 12/26/2024 For the treatment of chronic idiopathic constipation in adults 75 215971 Deutetrabenazine Tablets Aurobindo Pharma Limited Austedo Tablets 12/26/2024 For the treatment in …
FDA’s role in drug recalls A recall may be recommended or requested by FDA or initiated voluntarily at any time by a company. FDA’s role in a recall is to oversee a company’s recall strategy and ensure adequate steps were taken to implement the recall. FDA …
For Immediate Release: October 23, 2025 The U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete and reviewable. …
