New Drug Approvals Archive - April 2017

Austedo (deutetrabenazine) Tablets - formerly SD-809

Date of Approval: April 3, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Huntington's 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.

• Teva Announces FDA Approval of Austedo (deutetrabenazine) for the Treatment of Chorea Associated with Huntington’s Disease
• Austedo (deutetrabenazine) FDA Approval History

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.

• Neurocrine Announces FDA Approval of Ingrezza (valbenazine) as the First and Only Approved Treatment for Adults with Tardive Dyskinesia (TD)
• Ingrezza (valbenazine) FDA Approval History

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.

• FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade
• Renflexis (infliximab-abda) FDA Approval History

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.

• Inspirion Delivery Sciences Receives FDA Approval for RoxyBond (oxycodone hydrochloride) Immediate Release Tablets with Abuse-Deterrent Label Claims
• RoxyBond (oxycodone hydrochloride) FDA Approval History

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.

• FDA Approves Xatmep (methotrexate) Oral Solution
• Xatmep (methotrexate) FDA Approval History

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.

• FDA Approves Brineura (cerliponase alfa) for CLN2 Disease, a Form of Batten Disease
• Brineura (cerliponase alfa) FDA Approval History

Rydapt (midostaurin) Capsules - formerly PKC412

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

• FDA Approves Rydapt (midostaurin) for FLT3-Mutated Acute Myeloid Leukemia and Systemic Mastocytosis
• Rydapt (midostaurin) FDA Approval History

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.

• FDA Approves Tymlos (abaloparatide) for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
• Tymlos (abaloparatide) FDA Approval History

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 ALK-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

• Takeda Announces FDA Accelerated Approval of Alunbrig (brigatinib)
• Alunbrig (brigatinib) FDA Approval History