New Drug Approvals Archive - 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.

• FDA Approves Vyzulta (latanoprostene bunod) Ophthalmic Solution for Open-Angle Glaucoma, Ocular Hypertension
• Vyzulta (latanoprostene bunod) FDA Approval History

Alecensa (alectinib)

New Indication Approved: November 6, 2017

• FDA Approves Alecensa (alectinib) as First-Line Treatment for ALK-Positive Metastatic Non-Small Cell Lung Cancer
• Alecensa (alectinib) FDA Approval History

Zelboraf (vemurafenib)

New Indication Approved: November 6, 2017

• FDA Approves Zelboraf (vemurafenib) for Erdheim-Chester Disease with BRAF V600 Mutation
• Zelboraf (vemurafenib) FDA Approval History

Auryxia (ferric citrate)

New Indication Approved: November 7, 2017

• FDA Approves Auryxia (ferric citrate) Tablets as a Treatment for People with Iron Deficiency Anemia and Chronic Kidney Disease, Not on Dialysis
• Auryxia (ferric citrate) FDA Approval History

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.

• FDA Approves Prevymis (letermovir) for Prevention of Cytomegalovirus (CMV) Infection and Disease in Adult Allogeneic Stem Cell Transplant Patients
• Prevymis (letermovir) FDA Approval History

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.

• Dynavax Announces FDA Approval of Heplisav-B for Prevention of Hepatitis B in Adults
• Heplisav-B (hepatitis B vaccine, recombinant (adjuvanted)) FDA Approval History

Adcetris (brentuximab vedotin)

New Indication Approved: November 9, 2017

• Seattle Genetics Announces FDA Approval of Adcetris (Brentuximab Vedotin) for Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) and CD30-Expressing Mycosis Fungoides (MF)
• Adcetris (brentuximab vedotin) FDA Approval History

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).

• FDA Approves Cinvanti (aprepitant) Injectable Emulsion for the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting (CINV)
• Cinvanti (aprepitant) FDA Approval History

Sprycel (dasatinib)

Patient Population Altered: November 9, 2017

• FDA Expands Approval of Sprycel (dasatinib) to Include Treatment of Children with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase
• Sprycel (dasatinib) FDA Approval History

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.

• FDA Approves Abilify MyCite (aripiprazole) Pill with Sensor to Digitally Track if Patients Have Ingested Their Medication
• Abilify MyCite (aripiprazole) FDA Approval History

Vraylar (cariprazine)

New Indication Approved: November 9, 2017

• Allergan Receives FDA Approval for Vraylar (cariprazine) in the Maintenance Treatment of Schizophrenia
• Vraylar (cariprazine) FDA Approval History

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.

• FDA Approves Fasenra (benralizumab) for Severe Eosinophilic Asthma
• Fasenra (benralizumab) FDA Approval History

Faslodex (fulvestrant)

New Indication Approved: November 14, 2017

• Faslodex (fulvestrant) Receives FDA Approval for the Treatment of Advanced Breast Cancer in Combination with Abemaciclib

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).

• FDA Approves Mepsevii (vestronidase alfa) for Mucopolysaccharidosis Type VII
• Mepsevii (vestronidase alfa) FDA Approval History

Tekturna (aliskiren)

New Dosage Form Approved: November 14, 2017

• Noden Pharma Announces FDA Approval of Tekturna (aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older
• Tekturna (aliskiren) FDA Approval History

Gazyva (obinutuzumab)

New Indication Approved: November 16, 2017

• FDA Approves Genentech’s Gazyva for Previously Untreated Advanced Follicular Lymphoma
• Gazyva (obinutuzumab) FDA Approval History

Hemlibra (emicizumab-kxwh) Injection

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

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 factor VIII inhibitors.

• FDA Approves Hemlibra (emicizumab-kxwh) for Hemophilia A with Inhibitors
• Hemlibra (emicizumab-kxwh) FDA Approval History

Sutent (sunitinib malate)

New Indication Approved: November 16, 2017

• FDA Approves Sutent (sunitinib malate) for Adjuvant Treatment of Adult Patients at High Risk of Recurrent Renal Cell Carcinoma
• Sutent (sunitinib malate) FDA Approval History

Auvi-Q (epinephrine)

Patient Population Altered: November 17, 2017

• FDA Approves Kaléo’s Auvi-Q (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children
• Auvi-Q (epinephrine) FDA Approval History

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.

• FDA Approves Juluca (dolutegravir and rilpivirine) for the Maintenance Treatment of Virologically Suppressed HIV-1 Infection
• Juluca (dolutegravir and rilpivirine) FDA Approval History

Isentress (raltegravir)

Patient Population Altered: November 22, 2017

• Merck Receives FDA Approval for Isentress (raltegravir), in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Newborns Weighing at Least 2 kg
• Isentress (raltegravir) FDA Approval History

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.

• FDA Approves Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution for Colonoscopy Prep
• Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) FDA Approval History

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).

• FDA Approves Sublocade (buprenorphine) Once-Monthly Injection for Opioid Use Disorder
• Sublocade (buprenorphine) FDA Approval History

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.

• Dr. Reddy’s Announces Approval of Impoyz (clobetasol propionate) Cream for Plaque Psoriasis
• Impoyz (clobetasol propionate) FDA Approval History