💊FDA Confirms RIFADIN Capsules Not Withdrawn for Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that RIFADIN (rifampin) capsules, 150 milligrams (mg) and 300 mg, were not withdrawn from sale for reasons of safety or effectiveness to the extent that the drugs can be manufactured or formulated in a manner that satisfies any applicable acceptable intake limit for nitrosamine impurities. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements, including satisfying any applicable acceptable intake limit for nitrosamine impurities.
Learn More💊DEA Notice on Experic LLC's Importer Application for Controlled Substances
Experic 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💊DEA Notice
Chattem Chemicals has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊DEA Notice
Veterans Pharmaceuticals, Inc. 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💊Cambrex Charles City Seeks Registration for Controlled Substance Manufacturing
Cambrex Charles City has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn More💊FDA Seeks Input on Onshoring Drug Manufacturing
The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to solicit public comments on issues related to accelerating the establishment of new pharmaceutical manufacturing facilities in the United States. FDA is also announcing the following public meeting entitled "Onshoring Manufacturing of Drugs and Biological Products." At this meeting, FDA will present a draft framework that seeks to facilitate onshoring of pharmaceutical manufacturing. Participants will then engage in a guided discussion regarding the proposed framework, its strengths, weaknesses, and opportunities. The group will also discuss additional considerations that may help overcome current challenges faced by industry to onshoring the manufacturing of pharmaceuticals, including active pharmaceutical ingredients (APIs) and finished drug and biological products, and ideas and options within the bounds of FDA's statutory authority that could facilitate such onshoring of manufacturing.
Learn More💊FDA Notice on Withdrawal of Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 15, 2025.
Learn More💊FDA Affirms ROXICET Availability for Generic Drug Applications
The Food and Drug Administration (FDA or Agency) has determined that ROXICET (oxycodone hydrochloride (HCl) and acetaminophen) tablet, 5 milligrams (mg)/325 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 oxycodone HCl and acetaminophen tablet, 5 mg/ 325 mg, if all other legal and regulatory requirements are met.
Learn More💊FDA Reopens Comment Period on Prescription Drug User Fee Act VII
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability entitled "Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Request for Comments" that appeared in the Federal Register of May 9, 2025. In the notice of availability, FDA requested comments on the final assessment report. The Agency is taking this action in response to a request to allow interested persons additional time to submit comments.
Learn More💊FDA Withdraws Approval of 39 New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 39 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