Meridian Medical Technologies, Mylan's manufacturing partner for the EpiPen Auto-Injector, expanded a voluntary recall of the EpiPen and EpiPen Jr. epinephrine auto-Injectors to now include additional lots distributed in the United States and other markets.
Christine Blank, Contributing Editor
While FDA just approved the first drug for primary progressive multiple sclerosis (PPMS), the drug’s price tag is controversial.
FDA approved the first treatment for metastatic Merkel cell carcinoma (MCC), a rare, aggressive skin cancer.
FDA approved safinamide (Xadago, Newron Pharmaceuticals) tablets as an add-on treatment for patients with Parkinson’s disease. FDA also approved new treatments for classical Hodgkin lymphoma and pemphigus vulgaris, a rare, life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.
Pharmaceutical manufacturers and some consumer groups praised President Donald Trump’s nomination of Dr. Scott Gottlieb as the new FDA commissioner.
Mylan received approval from FDA to market its desvenlafaxine extended-release tablets, the generic version of Pristiq (Pfizer), for major depressive disorder. Plus, 2 other manufacturers recently received approval for their generic versions of Pristiq.
FDA recently approved three novel drugs: one to treat frequent urination at night, one to treat carcinoid syndrome diarrhea in cancer patients, and one for dust mite allergies. Here are the details on the three new treatments.
FDA approved 10 mg dapagliflozin and 5 mg saxagliptin (Qtern, AstraZeneca), to treat type 2 diabetes.