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New Drug Approvals Archive - April 2017

See also: New Indications and Dosage Forms for April 2017

April 2017

Austedo (deutetrabenazine) Tablets - formerly SD-809

Date of Approval: April 3, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Huntington Disease, Tardive Dyskinesia

Austedo (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease and the treatment of tardive dyskinesia.

Ingrezza (valbenazine) Capsules

Date of Approval: April 11, 2017
Company: Neurocrine Biosciences, Inc.
Treatment for: Tardive Dyskinesia

Ingrezza (valbenazine) is a novel, highly-selective VMAT2 inhibitor for the treatment of tardive dyskinesia.

Renflexis (infliximab-abda) Injection

Date of Approval: April 21, 2017
Company: Samsung Bioepis Co., Ltd.
Treatment for: Crohn's Disease -- Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Renflexis (infliximab-abda) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

RoxyBond (oxycodone hydrochloride) Tablets

Date of Approval: April 20, 2017
Company: Inspirion Delivery Sciences, LLC
Treatment for: Pain

Marketing Status: Discontinued

RoxyBond (oxycodone hydrochloride) is an immediate-release, abuse-deterrent, narcotic analgesic formulation for the management of severe pain.

Xatmep (methotrexate) Oral Solution

Date of Approval: April 25, 2017
Company: Silvergate Pharmaceuticals, Inc.
Treatment for: Acute Lymphoblastic Leukemia, Juvenile Idiopathic Arthritis

Xatmep (methotrexate) is a folate analog metabolic inhibitor in an oral solution formulation indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and for the management of pediatric patients with active polyarticular juvenile idiopathic arthritis.

Brineura (cerliponase alfa) Injection

Date of Approval: April 27, 2017
Company: BioMarin Pharmaceutical Inc.
Treatment for: CLN2 Disease

Brineura (cerliponase alfa) is an enzyme replacement therapy for the restoration of tripeptidyl peptidase-1 (TPP1) enzyme activity in patients with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), or TPP1 deficiency, a form of Batten disease.

Rydapt (midostaurin) Capsules - formerly PKC412

Date of Approval: April 28, 2017
Company: Novartis
Treatment for: Acute Myeloid Leukemia, Mastocytosis

Rydapt (midostaurin) is an oral, multi-targeted kinase inhibitor for the treatment of acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, and for the treatment of advanced systemic mastocytosis (SM), which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) and mast cell leukemia.

Tymlos (abaloparatide) Injection

Date of Approval: April 28, 2017
Company: Radius Health, Inc.
Treatment for: Osteoporosis

Tymlos (abaloparatide) is a synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein) for the treatment of postmenopausal women with osteoporosis.

Alunbrig (brigatinib) Tablets

Date of Approval: April 28, 2017
Company: Takeda Pharmaceutical Company Limited
Treatment for: Non-Small Cell Lung Cancer

Alunbrig (brigatinib) is an anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is resistant to crizotinib.

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