New Drug Approvals Archive - August 2017

Opdivo (nivolumab)

New Indication Approved: July 31, 2017

• Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment
• Opdivo (nivolumab) FDA Approval History

Kalydeco (ivacaftor)

New Indication Approved: July 31, 2017

• FDA Approves Kalydeco (ivacaftor) for People Ages 2 and Older With Cystic Fibrosis Who Have Certain Residual Function Mutations
• Kalydeco (ivacaftor) FDA Approval History

Idhifa (enasidenib) Tablets

Date of Approval: August 1, 2017
Company: Celgene Corporation
Treatment for: Acute Myeloid Leukemia

Idhifa (enasidenib) is a first-in-class, oral, targeted inhibitor of mutant isocitrate dehydrogenase 2 (IDH2) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation.

• FDA Approves Idhifa (enasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with IDH2 Mutation
• Idhifa (enasidenib) FDA Approval History

Epclusa (sofosbuvir and velpatasvir)

Patient Population Altered: August 1, 2017

• FDA Approves Expanded Labeling for Epclusa (sofosbuvir/velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV
• Epclusa (sofosbuvir and velpatasvir) FDA Approval History

Imbruvica (ibrutinib)

New Indication Approved: August 1, 2017
Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma; Chronic Graft Versus Host Disease

• FDA Approves Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease
• Imbruvica (ibrutinib) FDA Approval History

Vyxeos (cytarabine and daunorubicin) Injection

Date of Approval: August 3, 2017
Company: Jazz Pharmaceuticals plc
Treatment for: Acute Myeloid Leukemia

Vyxeos (cytarabine and daunorubicin liposome injection) is a liposomal combination of cytarabine, a nucleoside metabolic inhibitor, and daunorubicin, an anthracycline topoisomerase inhibitor, indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

• FDA Approves Vyxeos (daunorubicin and cytarabine) Liposome for Injection for Certain Types of Poor-Prognosis Acute Myeloid Leukemia
• Vyxeos (cytarabine and daunorubicin) FDA Approval History

Mavyret (glecaprevir and pibrentasvir) Tablets

Date of Approval: August 3, 2017
Company: AbbVie Inc.
Treatment for: Chronic Hepatitis C

Mavyret (glecaprevir/pibrentasvir) is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, indicated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C.

• FDA Approves Mavyret (glecaprevir and pibrentasvir) for Hepatitis C
• Mavyret (glecaprevir and pibrentasvir) FDA Approval History

Liletta (levonorgestrel)

New Indication Approved: August 3, 2017

• FDA Approves Medicines360's sNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Four Years
• Liletta (levonorgestrel) FDA Approval History

CaroSpir (spironolactone) Oral Suspension

Date of Approval: August 4, 2017
Company: CMP Pharma, Inc.
Treatment for: Congestive Heart Failure, Edema, Hypertension

CaroSpir (spironolactone) is an oral suspension formulation of the potassium-sparing diuretic spironolactone indicated for the treatment of heart failure, management of edema, and for use as an add-on therapy in the treatment of hypertension.

• CMP Pharma, Inc. Announces FDA Approval of CaroSpir (spironolactone) Oral Suspension
• CaroSpir (spironolactone) FDA Approval History

Besponsa (inotuzumab ozogamicin) for Injection

Date of Approval: August 17, 2017
Company: Pfizer Inc.
Treatment for: Acute Lymphoblastic Leukemia

Besponsa (inotuzumab ozogamicin) is a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

• FDA Approves Besponsa (inotuzumab ozogamicin) for Relapsed or Refractory Acute Lymphoblastic Leukemia
• Besponsa (inotuzumab ozogamicin) FDA Approval History

Lynparza (olaparib)

New Dosage Form Approved: August 17, 2017

• FDA Approves Tablet Formulation of Lynparza (olaparib) for Maintenance Treatment of Ovarian Cancer
• Lynparza (olaparib) FDA Approval History

Duzallo (allopurinol and lesinurad) Tablets

Date of Approval: August 18, 2017
Company: Ironwood Pharmaceuticals, Inc.
Treatment for: Gout

Duzallo (allopurinol and lesinurad) is a xanthine oxidase inhibitor and URAT1 inhibitor fixed-dose combination for the treatment of hyperuricemia in patients with uncontrolled gout.

• FDA Approves Duzallo (lesinurad and allopurinol) for Hyperuricemia in Patients with Uncontrolled Gout
• Duzallo (allopurinol and lesinurad) FDA Approval History

Gocovri (amantadine hydrochloride) Extended-Release Capsules - formerly ADS-5102

Date of Approval: August 24, 2017
Company: Adamas Pharmaceuticals, Inc.
Treatment for: Levodopa-Induced Dyskinesia

Gocovri (amantadine hydrochloride) is a chrono-synchronous amantadine therapy for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease.

• FDA Approves Gocovri (amantadine) for the Treatment of Dyskinesia in Parkinson's Disease Patients
• Gocovri (amantadine hydrochloride) FDA Approval History

Victoza (liraglutide)

New Indication Approved: August 25, 2017

• Victoza (liraglutide) is Approved to Reduce the Risk of Three Major Adverse Cardiovascular Events in Type 2 Diabetes Patients
• Victoza (liraglutide) FDA Approval History

KedRAB (rabies immunoglobulin human) Injection

Date of Approval: August 23, 2017
Company: Kamada Ltd. and Kedrion S.p.A.
Treatment for: Rabies Prophylaxis

KedRAB [rabies immunoglobulin (human)] is a human plasma derived anti-rabies immunoglobulin indicated for post-exposure prophylaxis (PEP) of rabies infection.

• FDA Approves KedRAB [rabies immune globulin (Human)] for Post-Exposure Prophylaxis of Rabies Infection
• KedRAB (rabies immunoglobulin human) FDA Approval History

Faslodex (fulvestrant)

New Indication Approved: August 25, 2017

• Faslodex (fulvestrant) Receives FDA Approval as Monotherapy for Expanded Use in HR+, HER2- Advanced Breast Cancer

Cyltezo (adalimumab-adbm) Injection

Date of Approval: August 25, 2017
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease -- Acute, Crohn's Disease -- Maintenance, Ulcerative Colitis, Plaque Psoriasis

Cyltezo (adalimumab-adbm) is an anti-TNF-α monoclonal antibody biosimilar to Humira, approved for the treatment of various inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

• FDA Approves Cyltezo (adalimumab-adbm), a Biosimilar to Humira
• Cyltezo (adalimumab-adbm) FDA Approval History

(benznidazole) Tablets

Date of Approval: August 29, 2017
Company: Chemo Research, S. L.
Treatment for: Chagas Disease

Benznidazole is an antiprotozoal indicated for the treatment of Chagas disease, or American trypanosomiasis, a parasitic infection caused by Trypanosoma cruzi.

• FDA Approves Benznidazole as First U.S. Treatment for Chagas Disease
• benznidazole FDA Approval History

Vabomere (meropenem and vaborbactam) Injection - formerly Carbavance

Date of Approval: August 29, 2017
Company: The Medicines Company
Treatment for: Urinary Tract Infection

Vabomere (meropenem and vaborbactam) is a carbapenem and beta-lactamase inhibitor combination for the treatment of complicated urinary tract infections (cUTIs).

• FDA Approves Vabomere (meropenem and vaborbactam) for Complicated Urinary Tract Infections
• Vabomere (meropenem and vaborbactam) FDA Approval History

Kymriah (tisagenlecleucel) Suspension for Intravenous Infusion - formerly CTL019

Date of Approval: August 30, 2017
Company: Novartis Pharmaceuticals Corporation
Treatment for: Acute Lymphoblastic Leukemia; Large B-Cell Lymphoma

Kymriah (tisagenlecleucel) is a chimeric antigen receptor T cell (CAR-T) therapy for use in patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and patients with relapsed or refractory (r/r) large B-cell lymphoma.

• FDA Approves Kymriah (tisagenlecleucel) CAR-T Gene Therapy for Acute Lymphoblastic Leukemia
• Kymriah (tisagenlecleucel) FDA Approval History

Austedo (deutetrabenazine)

New Indication Approved: August 30, 2017

• Teva Announces FDA Approval of Austedo (deutetrabenazine) Tablets for the Treatment of Tardive Dyskinesia in Adults
• Austedo (deutetrabenazine) FDA Approval History

Actemra (tocilizumab)

New Indication Approved: August 30, 2017

• FDA Approves Genentech’s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome
• Actemra (tocilizumab) FDA Approval History

Kymriah (tisagenlecleucel)

New Indication Approved: May 1, 2018
Treatment for: Acute Lymphoblastic Leukemia; Large B-Cell Lymphoma

• Kymriah (tisagenlecleucel) Receives Second FDA Approval to Treat Appropriate Patients with Large B-Cell Lymphoma
• Kymriah (tisagenlecleucel) FDA Approval History