American Pharmaceutical Review

American Pharmaceutical Review
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Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International announced it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between...

The U.S. Food and Drug Administration (FDA) issued a warning letter to Becton Dickinson (BD) & company that cited several violations of federal law, including marketing significantly modified versions of certain BD Vacutainer blood collection tubes without required FDA clearance or approval and failing to submit medical device reports to the FDA...

Fresenius Kabi has announced the availability in the United States of Bortezomib for Injection. Fresenius Kabi Bortezomib for Injection is available as a single dose vial containing 3.5 mg of lyophilized powder. Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical...

Baxter announced a distribution agreement for the U.S. launch of the Arisure Closed System Transfer device, which consists of several components that work together to help prevent contaminants from entering the intravenous (IV) medication delivery system and the escape of hazardous substances out of the system during drug preparation and...

PharMEDium Services is voluntarily expanding the recall issued on December 27, 2017 to include additional lots of sterile drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To...

Celgene and Impact Biomedicines announced the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera. Under the terms of the agreement, Celgene will pay approximately $1.1 billion upfront and up to $1.25 billion in contingent payments based on...

As we enter the new year and pass the 100-day mark from when Hurricane Maria made landfall in Puerto Rico, we want to provide an update on the current recovery efforts, the state of existing drug shortages that resulted from the impact of the storm and our continued commitment to help the island fully recover. A key area of focus for the FDA...

Takeda Pharmaceutical announced its intention to acquire TiGenix, an advanced biopharmaceutical company developing novel stem cell therapies for serious medical conditions, and as a result has entered into an offer and support agreement with TiGenix which provides for a recommended potential voluntary public takeover bid for TiGenix. The Takeda...

Rocket Pharmaceuticals announced the completion of its merger with Inotek Pharmaceuticals. The combined company will be named Rocket Pharmaceuticals and will focus on advancing a pipeline of gene therapy programs targeting rare and undertreated diseases. Rocket’s common stock will be listed on the NASDAQ Global Market under the symbol “RCKT” and is...

AuroMedics Pharma is voluntarily recalling lot AFO l 17001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product has been found to contain glass particles. Risk Statement: The...