• Mallinckrodt plc announced the U.S. Food and Drug Administration (FDA) has granted the company's request for a Fast Track designation for its Investigational New Drug (IND) application for Synacthen® Depot in the treatment of Duchenne muscular dystrophy (DMD). Synacthen Depot is a depot formulation of Synacthen (tetracosactide), a synthetic 24 amino acid melanocortin receptor agonist. Synacthen Depot is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions, but has never been approved for use in patients in the U.S.

  • Zealand Pharma (Zealand) announced that Sanofi has submitted updated information on the pen delivery device for iGlarLixi to the U.S. Food and Drug Administration (FDA) as part of the New Drug Application (NDA) for the product. IGlarLixi is a once-daily, fixed-ratio combination of lixisenatide (AdlyxinTM) and insulin glargine 100 Units/mL (Lantus®) for the treatment of adults with type 2 diabetes.

  • Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved TROXYCA® ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, for oral use, CII for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. TROXYCA ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. However, abuse of TROXYCA ER by these routes is still possible. It is the only oxycodone with oral abuse-deterrent features described in the labeling.

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  • AstraZeneca and Eli Lilly and Company (Lilly) today announced they have received US Food and Drug Administration (FDA) Fast Track designation for the development programme in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial.

  • Edwards Lifesciences Corporation announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic stenosis who have been determined by a Heart Team to be at intermediate risk for open-heart surgery. The SAPIEN 3 valve is the first transcatheter aortic valve replacement (TAVR) therapy to obtain this indication in the United States.

  • Amerigen Pharmaceuticals Limited  announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Temodar® (temozolomide capsules 5, 20, 100, 140, 180 and 250mg).

  • Zymeworks Inc., a biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics, including bi-specific antibodies and drug conjugates for the treatment of cancer, announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Zymeworks’ lead investigational products ZW25 and ZW33 for the treatment of ovarian cancer. Orphan drug designation qualifies Zymeworks for a number of development incentives including tax credits for clinical testing and marketing exclusivity for a period of seven years if ZW25 or ZW33 is approved for this indication.

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