Article

FDA Grants Flurry of Approvals Last Week

FDA approves 7 drugs and a device in less than a week.

Last week, the FDA approved a significant number of drugs and devices with the potential to improve disease management.

Between November 13, 2017, and November 16, 2017, the FDA approved 7 new drugs and a novel device that may improve symptom management for patients with opioid use disorder.

Here’s a recap of the approvals on AJPB:

  • Schizophrenia Maintenance Therapy Gets FDA Approval

​Cariprazine is a once-daily atypical antipsychotic for patients with bipolar I disorder and schizophrenia. Read more.

  • FDA Approves New Pediatric Leukemia Treatment

Dasatinib (Sprycel) approved for pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia. Read more.

  • FDA Approves First Drug with Ingestible Digital Adherence Sensor

Aripiprazole tablets with sensor (Abilify MyCite) is approved to treat schizophrenia, manic and mixed episodes for patients with bipolar I disorder, and as an add-on for depression treatment. Read more.

  • FDA Approves Drug for Rare Inherited Genetic Condition

Vestronidase alfa-vjbk (Mepsevii) approved mucopolysaccharidosis type VII, an extremely rare metabolic condition is also known as Sly syndrome. Read more.

  • FDA Authorizes Device for Opioid Withdrawal Treatment

The NSS-2 Bridge device reduced opioid withdrawal symptoms more than 31% within 30 minutes of treatment. Read more.

  • FDA Approves Biologic Drug for Eosinophilic Asthma

Benralizumab is a monoclonal antibody that causes natural killer immune cells to reduce eosinophils. Read more.

  • Hemlibra Gets FDA Approval to Treat Hemophilia A

Emicizumab-kxwh is administered as a weekly subcutaneous injection to restore clotting ability in patients with hemophilia. Read more.

  • Sutent Receives FDA Approval for Renal Cell Carcinoma

Sunitinib malate (Sutent) is an adjuvant therapy for adults at risk of recurrent renal cell carcinoma following nephrectomy. Read more.

Newsletter

Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights.

Related Videos
Tired scared retiree man holding chest with anginal symptoms, pallor and diaphoresis at home. Suffering male with cardiac origin pain, prexcordial pressure, arrhythmia risk, urgent medical attention - Image credit: DimaBerlin | stock.adobe.com
5 experts in this video
Image credit: Sebastian Kaulitzki | stock.adobe.com
1 expert is featured in this series.
Magnified bone marrow biopsy showing plasma cells with irregular nuclei and multiple myeloma tumor cells infiltrating normal hematopoietic tissue
Health and nutrition: the role of glp-1 in diabetes management with apple and syringe - Image credit: Thanayut | stock.adobe.com