New Drug Approvals Archive - August 2017

August 2017

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.

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).

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.

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.

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).

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.

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.

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.

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, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

(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.

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).

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.