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Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 208833 for Celecoxib capsules, 50 milligrams (mg), 100 mg, 200 mg, and 400 mg, held by Amneal Pharmaceuticals of New York, LLC, 50 Horseblock Rd., Brookhaven, NY 11719 (Amneal). Amneal requested withdrawal of approval of this application and…
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Request for Comments on the Renewal of a Previously Approved Information Collection: Application and Reporting Elements for Participation in the Tanker Security Program
MARAD invites public comments on its intention to request Office of Management and Budget (OMB) approval to renew an information collection in accordance with the Paperwork Reduction Act of 1995. The proposed collection OMB 2133-0554 (Application and Reporting Elements for Participation in the Tanker Security Program) is used to evaluate the eligibility of applicants for…
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Request for Comments on the Renewal of a Previously Approved Information Collection: War Risk Insurance, Applications, and Related Information
MARAD invites public comments on its intention to request Office of Management and Budget (OMB) approval to renew an information collection in accordance with the Paperwork Reduction Act of 1995. The proposed collection OMB 2133- 0011 (War Risk Insurance, Applications, and Related Information) is used to obtain war risk insurance from the U.S. Government, when…
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Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 37 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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National Environmental Policy Act Implementing Procedures: Wintertime Oil and Gas Exploration in the National Petroleum Reserve in Alaska Categorical Exclusion
This notice announces a revision to the Department of the Interior (Department)’s National Environmental Policy Act (NEPA) procedures adding a new categorical exclusion (CE) for National Petroleum Reserve in Alaska (NPR-A) wintertime oil and gas exploration activities to the DOI Handbook of NEPA Implementing Procedures, Appendix 2: Bureau Categorical Exclusions.
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Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that LASIX (furosemide) oral solution, 10 milligrams (mg)/ milliliter (mL), 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…
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
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Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MONOFERRIC 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,…
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Notice of Availability of the Proposed Notice of Sale for Gulf of America Outer Continental Shelf Oil and Gas One Big Beautiful Bill Act Lease Sale 4
The Bureau of Ocean Energy Management (BOEM) announces the availability of the Proposed Notice of Sale (NOS) for the Gulf of America (GOA) Outer Continental Shelf (OCS) Oil and Gas One Big Beautiful Bill Act (OBBBA) Lease Sale 4 (Lease Sale BBG4). BOEM is publishing this Notice pursuant to its regulatory authority under 30 CFR…
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
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Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZANVASTRO (Zilganersen)
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. 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…