FDA Grants Flurry of Approvals Last 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.