Enforcement Report - Week of May 25, 2022
Shares of Sun Pharma Advanced Research Company (SPARC) fell 5 percent intraday on October 7 even after the company received orphan drug designation from USFDA for Phenobarbital used in the treatment of patients with neonatal seizures.
Health Canada Issues Recall of Pharmascience`s Phenobarb 30mg Tablet
Enforcement Report - Week of August 30, 2017
The FDA has classified the ongoing recall by drug wholesaler Truxton of 18 lots of phenobarbital and amitriptyline tablets as Class I and Class II recalls.
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that it has entered into a commercialization agreement with ParaPRO LLC (“ParaPRO”), an Indiana-based specialty pharmaceutical company, granting RedHill the exclusive rights to promote Esomeprazole Strontium Delayed-Release Capsules to gastroenterologists in certain U.S. territories.
C.O.Truxton, Inc. Issues Voluntary Nationwide Recall of Amitriptyline HCL & Phenobarbital Tablets Due to Potential Label Mix-Up
C.O. Truxton, Inc. Issues Voluntary Nationwide Recall of Phenobarbital 15 mg Tablets, USP due to Labeling Error on Declared Strength
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today presented positive results from the LATTE-2 study at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston. Headline results were announced in November 2015.
RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced the signing of an exclusive co-promotion agreement with a subsidiary of Concordia International Corp. (Concordia), an international specialty pharmaceutical company, granting RedHill certain US promotion rights for Donnatal, a prescription oral drug used with other drugs in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel).