FDA Approvals - Akorn-Strides, LLC Announces FDA The Approvals Of Two ANDAs For
Akorn-Strides, LLC Announces FDA The Approvals Of Two ANDAs For Ondansetron Injection USP (Medical News Today)
Akorn-Strides, LLC announced the approvals of two ANDAs for Ondansetron Injection USP, 4 mg/2mL Single Dose Vials and Ondansetron Injection USP, 40 mg/20mL Multiple Dose Vials. Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn, Inc. (NASDAQ: AKRX) and Strides Arcolab Limited (NSE: STAR)(BSE: 532531).
FDA Ends Probe Of Watson Pharmaceuticals Plant (Manufacturing.net)
Food and Drug Administration ended its years-long scrutiny of the drug maker's Davie, Fla., manufacturing plant, allowing products made there to be eligible for FDA approval.
Acusphere Submits New Drug Application for FDA Approval of Imagify(TM) (Centre Daily Times)
Acusphere Inc. (NASDAQ: ACUS) announced today the submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for approval to market its lead product candidate, Imagify(TM) (Perflubutane Polymer Microspheres for Injectable Suspension). Imagify is an ultrasound imaging agent for the detection of coronary artery disease, the leading cause of death in the United States. ...