This quarterly review of new drug applications contain data for applications approved for the first time during the third quarter of 2019 which includes New Molecular Entities (NMEs) and new biologics. A total of 36 applications were approved by the FDA during these three months.
Following are the percentages of various dosage form classifications in this quarter - 30.6% tablets (11), 16.7% capsules (6), 33.3% injectable formulations (12), 8.33% oral solutions or suspensions (3), and 11.1% for others (4). Others include two medical gases, one nasal powder and one unknown.
In July 2019, the FDA approved Baqsimi nasal powder for the treatment of severe hypoglycemia in patients with diabetes ages four and older. Baqsimi is a nasal powder of glucagon, an antihypoglycemic agent. It is the first glucagon nasal therapy approved for the emergency treatment of severe hypoglycemia. People living with diabetes who are using insulin treatment typically suffer from severe hypoglycemia. Patients are at risk when their blood sugar levels fall below the normal range and they become unconscious. In this situation, they require assistance from another person to treat.
Until recently, Glucagon was only available as an injection which required multiple steps of mixing prior to administration. Baqsimi, is administered nasally and it comes with a single-use dispenser, which can be quickly given to someone suffering from a severe hypoglycemic episode.
Xpovio (selinexor) tablets in combination with dexamethasone obtained an accelerated approval for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Genentech’s Rozlytrek also obtained an accelerated approval, which is used to treat people with ROS1-positive, metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumors.
It is not common to get an approval for medical gases. Products containing helium USP was approved to AGL Welding Supply Company and Roberts Oxygen Co. Inc.