- The FDA has a busy docket this week with two Ad Comm meetings and four product approval decisions.
- On Tuesday, the Circulatory System Devices Panel of the Medical Devices Advisory Committee will discuss the Premarket Approval Application (PMA) from St. Jude Medical (STJ -0.2%) seeking approval of its AMPLATZER Patent Foramen Ovale (PFO) Occluder, a permanent cardiac implant for PFO closure indicated for preventing recurrent ischemic stroke in patients who have had a cryptogenic (uncertain origin) stroke due an embolism presumed to have originated through an opening in the heart.
- On Wednesday, the Endocrinologic and Metabolic Drugs Advisory Committee will review the NDAs for Sanofi's (SNY -1.3%) fixed ratio combination of insulin glargine and lixisenatide for the treatment of adults with type 2 diabetes.
- No later than Thursday, the FDA will decide on Sarepta Therapeutics' (SRPT +2.3%) New Drug Application (NDA) seeking approval of eteplirsen for children with Duchenne muscular dystrophy amenable to skipping exon 51. Also, no later than Thursday, it will decide on AstraZeneca's (AZN -0.3%) NDA seeking approval of ZS-9 for hyperkalemia.
- No later than Friday, the agency will decide on Titan Pharmaceuticals' (TTNP +8.8%) NDA seeking approval of its Probuphine subdermal implant for the maintenance treatment of opioid addiction. Also, no later than Friday, it will decide on Vanda Pharmaceuticals' (VNDA +0.3%) supplemental NDA seeking approval of Fanapt for the maintenance (long term) treatment of schizophrenia in adults.