FDA Approval

FDA clears first opioid withdrawal deviceFDA granted a new indication to a device that can help reduce the symptoms of withdrawal from the prescription pain drugs.
FDA approves first pill that can be tracked when ingestedFDA approved the first drug in the United States that has a digital ingestion tracking system, which records when the medication was taken.
FDA okays unique injectable for type 2 diabeticsFDA approvedĀ a new once-weekly, single-dose autoinjector device to improve glycemic control in adults with type 2 diabetes.
FDA alters stance on opioid addiction drugs
FDA alters stance on opioid addiction drugsFDA is advising that these 2 opioid addiction medications should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system.
FDA expands cystic fibrosis treatmentFDA expanded the use of ivacaftor (Kalydeco, Vertex Pharmaceuticals) to treat cystic fibrosis.
FDA clears second Remicade biosimilarIn what is expected to produce hefty saving for rheumatoid arthritis patients and the healthcare system, FDA approved the second biosimilar to Remicade (Johnson & Johnson).
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.
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.
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.
Advanced ovarian cancer drug approvedFDA recently approved rucaparib (Rubraca, Clovis Oncology) tablets to treat patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer, who have been treated with 2 or more chemotherapies.