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 Disease

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

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

Austedo (deutetrabenazine) FDA Approval History

Harvoni (ledipasvir and sofosbuvir)

Patient Population Altered: April 7, 2017

• FDA Approves Harvoni (ledipasvir and sofosbuvir) for Chronic Hepatitis C Infection in Pediatric Patients 12 Years and Older

Harvoni (ledipasvir and sofosbuvir) FDA Approval History

Sovaldi (sofosbuvir)

Patient Population Altered: April 7, 2017

• FDA Approves Sovaldi (sofosbuvir) for Chronic Hepatitis C Infection in Pediatric Patients 12 Years and Older

Sovaldi (sofosbuvir) 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

Tecentriq (atezolizumab)

New Indication Approved: April 17, 2017

• FDA Grants Genentech’s Tecentriq (atezolizumab) Accelerated Approval as Initial Treatment for Certain People with Advanced Bladder Cancer

Tecentriq (atezolizumab) FDA Approval History

Lucentis (ranibizumab)

New Indication Approved: April 15, 2017
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

• FDA Approves Genentech’s Lucentis (ranibizumab) for all Forms of Diabetic Retinopathy

Lucentis (ranibizumab) 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

Praluent (alirocumab)

New Dosage Regimen: April 24, 2017
Treatment for: High Cholesterol

• Sanofi and Regeneron Announce FDA Approval of a New Once-Monthly Dosing Option for Praluent (alirocumab) Injection

Praluent (alirocumab) FDA Approval History

RoxyBond (oxycodone hydrochloride) Tablets

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

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

Stivarga (regorafenib)

New Indication Approved: April 27, 2017

• FDA Expands Approved Use of Stivarga (regorafenib) to Treat Hepatocellular Carcinoma

Stivarga (regorafenib) 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, 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 anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is resistant to crizotinib.

• Takeda Announces FDA Accelerated Approval of Alunbrig (brigatinib)

Alunbrig (brigatinib) FDA Approval History