Enforcement Report - Week of February 1, 2023
Enforcement Report - Week of February 2, 2022
Sandoz, a Novartis division, has successfully completed the acquisition of GSK’s cephalosporin antibiotics business. The transaction, which including leading global brand Zinnat, complements Sandoz leadership in generic penicillins with a leading position in cephalosporins.
This summer, Pfizer teamed up with other Big Pharmas on a $1 billion fund to bolster struggling antibiotics makers. Now, the company is adding a new antibiotic candidate to its pipeline through its acquisition of Arixa. If approved, the prospect could be the first new drug of its kind in more than 35 years.
Enforcement Report - Week of May 6, 2020
B. Braun Medical Issues Voluntary Nationwide Recall of One (1) Lot of Ceftazidime for Injection USP and Dextrose Injection USP
Sihuan Pharmaceutical Holdings Group Ltd, one of the largest cardio-cerebral vascular drug manufacturer in China’s prescription drug marke, announced that the “non-PVC solid-liquid double chamber bag for ceftazidime/sodium chloride injection” jointly developed by the Group and its associated company Beijing Ruiye Drugs Manufacture Co. Ltd has been granted drug registration approval by the National Medical Products Administration (NMPA) of the People’s Republic of China. All the ceftazidime currently approved for production in China are powder injection. The Group is the first company that has been granted drug registration approval for “non-PVC solid-liquid double chamber bag for ceftazidime/sodium chloride injection” in China.
White House Pharmacy Receives Form 483
Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant bacterial infections, today announced the appointment of David Melnick, M.D., as Chief Medical Officer to oversee Spero’s clinical development and regulatory strategy. Dr. Melnick brings significant clinical experience to Spero with 18 years in anti-infective drug development including seven successful anti-infective drug approvals.
Allergan has won US approval for its fixed-dose combination antibiotic Avycaz in a new indication, becoming the first new drug to treat pneumonia caused by Gram-negative bacterial infections in more than 15 years.