💉FDA Updates on Susceptibility Test Interpretive Criteria Announced
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Learn More💊FDA Confirms FLUMADINE Not Withdrawn for Safety or Effectiveness
The Food and Drug Administration (FDA, the Agency, or we) has determined that FLUMADINE (rimantadine hydrochloride) tablet, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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 Decision on ETHYOL
The Food and Drug Administration (FDA, the Agency, or we) has determined that ETHYOL (amifostine) for injection, 500 milligrams (mg)/ vial, was not withdrawn from sale for reasons of safety or effectiveness.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 Confirms NASCOBAL Status, Impacting Generic Approvals
The Food and Drug Administration (FDA, Agency, or we) has determined that NASCOBAL (cyanocobalamin) nasal spray, 0.5 milligram (mg)/spray, was not withdrawn from sale for reasons of safety or effectiveness.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 for 18 New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 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💊USITC Notice of Complaint on Certain Drug Products and Public Interest
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Drug Products Containing C-Type Natriuretic Peptide Variants, and Components Thereof, DN 3819; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.
Learn More💊AstraZeneca's FTZ Production Notification for Pharmaceuticals
AstraZeneca Pharmaceuticals LP has submitted a notification for proposed production activities related to zibotentan/dapagliflozin tablets in Foreign-Trade Zone (FTZ) 177 in Indiana. The notification aligns with FTZ regulations, detailing duty-free benefits for specified foreign-status materials and products while inviting public comment on the proposal.
Learn More⚖️DEA Revokes Prescript Pharmaceuticals' Registration for Violations
The Drug Enforcement Administration issued an Order of Revocation against Prescript Pharmaceuticals after it violated federal regulations pertaining to the procurement of controlled substances. The order highlights the importance of compliance with the Controlled Substances Act, especially concerning the requirement for obtaining procurement quotas for manufacturing activities, and could set a precedent affecting other registrants.
Learn More💊NIH Notice of Closed Meeting for Drug Development Contract Proposals
The National Center for Advancing Translational Sciences announces a closed meeting for evaluating contract proposals related to drug substance development. This meeting is a key opportunity for stakeholders in the health and pharmaceutical sectors to engage with the NIH as they assess various proposals.
Learn More💊Patheon API Services’ Application for Controlled Substances Import
Patheon API Services, 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.
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