FDA Approvals

Generic versions of major depression drug availableMylan 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.
Once-daily diabetes drug approvedFDA approved 10 mg dapagliflozin and 5 mg saxagliptin (Qtern, AstraZeneca), to treat type 2 diabetes.
Drug approved for nighttime urination, plus two moreFDA 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.
Tests help aid in antibiotic controlFDA recently approved 2 tests that will aid healthcare providers in determining which antibiotics are needed, leading to better antibiotics management.
Popular asthma inhaler now expanded to kidsA leading asthma inhaler will now be available to additional younger asthma patients, after FDA approved Spiriva Respimat (Boehringer Ingelheim) for the long-term, once-daily maintenance treatment of asthma in people age 6 and older.
Psoriasis drug approved with boxed warningA new drug to treat moderate-to-severe plaque psoriasis carries a black box warning that suicidal ideas and behavior, including completed suicides, have occurred in patients during the drug’s clinical trials.
Muscular dystrophy drug launch halts after pricing concernsMarathon Pharmaceuticals is temporarily pausing the launch of its drug to treat a rare form of muscular dystrophy (MD) after concerns over its $89,000 price tag.
New bladder cancer, kidney disease therapies availableFDA recently approved 2 new therapies: an expanded drug indication for locally advanced or metastatic urothelial carcinoma (mUC) and a treatment for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Diabetic patients challenge insulin makersIn the latest flap over the high cost of drugs, diabetes patients filed a class-action lawsuit against insulin makers.
Will Trump’s FDA picks speed drug approvals?Three candidates that President Donald Trump is considering for FDA Commissioner are likely to speed drug approvals, analysts say.