💊AJNA Biosciences Seeks Registration as Bulk Manufacturer of Controlled Substances
AJNA Biosciences 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💊Usona Institute Applies for Controlled Substance Manufacturing Registration
Usona Institute, Inc 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⚖️Proposed Scheduling of 4-Fluoroamphetamine as a Schedule I Substance
The Drug Enforcement Administration proposes placing the substance 4-fluoroamphetamine (4-FA; 1-(4-fluorophenyl)propan-2-amine), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle 4-fluoroamphetamine.
Learn More⚖️Correction on 2-Methyl AP-237 Placement in Schedule I by DEA
On March 15, 2024, the Drug Enforcement Administration published a final order placing 1-(2-methyl-4-(3-phenylprop-2-en-1- yl)piperazin-1-yl)butan-1-one (commonly known as 2-methyl AP-237), including its optical and geometric isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, in schedule I of the Controlled Substances Act. The effective date of that final order was 30 days after publication in the Federal Register. Before the effective date, DEA published another final order that made the instructions for 2-methyl AP-237 in the March 15 final order invalid. This document corrects that error, adding 2- methyl AP-237 and its drug code 9664 for regulatory purposes.
Learn More💊Proposed Production in Foreign-Trade Zone 189 for Pharmaceutical Products
The Department of Commerce has issued a notice regarding a proposed production activity by Grand River Aseptic Manufacturing within Foreign-Trade Zone 189 in Michigan, concerning the production of nivolumab and its active ingredient, atigotatug. Public comments are invited and will influence the approval process.
Learn More💊Exclusive Patent License for CNS Therapeutics by NIH
The National Institute of Neurological Disorders and Stroke and the National Center for Advancing Translational Sciences, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Psycala Bio, Inc. (Psycala), incorporated in Delaware.
Learn More💊FDA Draft Guidance on Bioequivalence for Immediate-Release Dosages
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is the second in the ICH M13 series of guidances and describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment for additional strengths of orally administered immediate-release (IR) solid oral dosage forms (i.e., tablets, capsules, and granules/powders for oral suspension), including considerations for biowaivers. The intent of this draft guidance is to provide harmonized criteria and data that support waivers for drug applications with multiple strengths when in vivo BE has been demonstrated for at least one strength using the principles outlined in the final guidance "M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms" published in October 2024.
Learn More💊FDA Determination on Epinephrine Supports Generic Drug Approvals
The Food and Drug Administration (FDA or Agency) has determined that EPINEPHRINE (epinephrine) solution, 1 milligram (mg)/ milliliter (mL), prefilled syringe for intravenous use, 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💊Notice on ANI Pharmaceuticals’ Controlled Substances Import Application
ANI 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💊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