Skip to Content

New Drug Approvals Archive - November 2017

See also: New Indications and Dosage Forms for November 2017

November 2017

Vyzulta (latanoprostene bunod) Ophthalmic Solution - formerly Vesneo

Date of Approval: November 2, 2017
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension

Vyzulta (latanoprostene bunod) is a nitric oxide donating prostaglandin receptor agonist for the treatment of patients with open angle glaucoma or ocular hypertension.

Prevymis (letermovir) Tablets and Injection

Date of Approval: November 8, 2017
Company: Merck & Co., Inc.
Treatment for: CMV Prophylaxis

Prevymis (letermovir) is a CMV DNA terminase complex inhibitor indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult allogeneic hematopoietic stem cell transplant patients.

Heplisav-B (hepatitis B vaccine, recombinant (adjuvanted)) Injection

Date of Approval: November 10, 2017
Company: Dynavax Technologies Corporation
Treatment for: Hepatitis B Prophylaxis

Heplisav-B (hepatitis B vaccine, recombinant (adjuvanted)) is a vaccine for use in the immunization against infection caused by all known subtypes of hepatitis B virus.

Cinvanti (aprepitant) Injection

Date of Approval: November 9, 2017
Company: Heron Therapeutics, Inc.
Treatment for: Nausea/Vomiting -- Chemotherapy Induced

Cinvanti (aprepitant) is a polysorbate 80 free, intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK 1) receptor antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Abilify MyCite (aripiprazole) Tablets with Sensor

Date of Approval: November 13, 2017
Company: Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health
Treatment for: Schizophrenia, Bipolar Disorder, Depression

Abilify MyCite (aripiprazole) is a tablet formulation of the approved atypical antipsychotic aripiprazole embedded with an ingestible Proteus® sensor that communicates with a wearable sensor patch and a medical software application to measure adherence in the treatment of adults with schizophrenia, bipolar I disorder, and major depressive disorder.

Fasenra (benralizumab) Injection

Date of Approval: November 14, 2017
Company: AstraZeneca
Treatment for: Asthma

Fasenra (benralizumab) is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody indicated for the treatment of patients with severe eosinophilic asthma.

Mepsevii (vestronidase alfa) Injection

Date of Approval: November 15, 2017
Company: Ultragenyx Pharmaceutical, Inc.
Treatment for: Mucopolysaccharidosis Type VII

Mepsevii (vestronidase alfa) is a recombinant human lysosomal beta glucuronidase indicated for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome).

Hemlibra (emicizumab-kxwh) Injection

Date of Approval: November 16, 2017
Company: Genentech, Inc.
Treatment for: Hemophilia A with Inhibitors, Hemophilia A

Hemlibra (emicizumab-kxwh) is a bispecific factor IXa- and factor X-directed antibody indicated to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

Juluca (dolutegravir and rilpivirine) Tablets

Date of Approval: November 21, 2017
Company: ViiV Healthcare
Treatment for: HIV Infection

Juluca (dolutegravir and rilpivirine) is a single-tablet, two-drug regimen of the approved drugs dolutegravir (Tivicay) and rilpivirine (Edurant) for the maintenance treatment of virologically suppressed HIV-1 infection.

Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution

Date of Approval: November 28, 2017
Company: Ferring Pharmaceuticals Inc.
Treatment for: Bowel Preparation

Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) is a stimulant laxative and osmotic laxative combination indicated for cleansing of the colon as a preparation for colonoscopy.

Sublocade (buprenorphine) Sustained-Release Injection - formerly RBP-6000

Date of Approval: November 30, 2017
Company: Indivior PLC
Treatment for: Opioid Use Disorder

Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the treatment of opioid use disorder (OUD).

Impoyz (clobetasol propionate) Cream

Date of Approval: November 28, 2017
Company: Dr. Reddy’s Laboratories Ltd.
Treatment for: Plaque Psoriasis

Impoyz (clobetasol propionate) is a high potency topical corticosteroid indicated for the treatment of moderate to severe plaque psoriasis.

New Drug Approvals Archive

More News Resources

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.