LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Nexus Pharmaceuticals LLC announced that the U.S. Food and Drug Administration (FDA) issued a notice in the Federal Register that ephedrine sulfate should not be bulked by compounding facilities. Bulking is the practice of an outsourcing facility to “compound a drug using a bulk drug substance.”1 The FDA explained that bulk compounding is allowed only where there is a drug shortage or “the bulk drug substance appears on a list” set by the FDA called “the 503B Bulks List.”2 Section 503B refers to the portion of the Drug Quality and Security Act setting forth requirements when certain compounded products may be allowed.
Enforcement Report - Week of June 7, 2023
Nexus Pharmaceuticals, Inc. Receives FDA Approval for EMERPHED® (ephedrine sulfate injection) Pre-Filled Syringe
DUBLIN, March 28, 2022 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) announced today that its Par Sterile Products business has begun shipping premixed Ephedrine Sulfate Injection in a ready-to-use 50 mg/10 ml single-use vial.
Gland Pharma's Generic Ephedrine Sulfate Receives Approval in the U.S.
FDA Confirms Para IV Patent Challenge for Ephedrine Sulfate injection (50mg/10ml)
Dr Reddy’s Laboratories Ltd announced the launch of ephedrine sulfate injection USP, 50 mg/mL, a therapeutic equivalent generic version of Akovaz injection, 50 mg/mL approved by the US Food and Drug Administration (FDA).
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Nexus Pharmaceuticals, Inc., a U.S.-based healthcare company and domestic pharmaceutical manufacturer, has received a patent covering applications of EMERPHED® Ready-To-Use Ephedrine Sulfate Injection, the first FDA-approved premixed ephedrine in a ready-to-use 50 mg/10 mL vial. The United States Patent and Trademark Office (USPTO) issued the patent, U.S. Patent No. 11,090,278, on August 17, 2021.
Aurobindo Pharma`s Generic Ephedrine Sulfate Receives Approval In US