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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 Prevention

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 (NK1) 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.

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