New Drug Approvals Archive - September 2017

Mylotarg (gemtuzumab ozogamicin) Injection

Date of Approval: September 1, 2017
Company: Pfizer Inc.
Treatment for: Acute Myeloid Leukemia

Mylotarg (gemtuzumab ozogamicin) is a D33-directed antibody-drug conjugate indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and the treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.

• FDA Approves Mylotarg (gemtuzumab ozogamicin) for the Treatment of Acute Myeloid Leukemia
• Mylotarg (gemtuzumab ozogamicin) FDA Approval History

Dotarem (gadoterate meglumine)

Patient Population Altered: August 25, 2017

• FDA Approves Guerbet's Dotarem (gadoterate meglumine) for Pediatric Patients Younger Than Two Years
• Dotarem (gadoterate meglumine) FDA Approval History

Tracleer (bosentan)

New Dosage Form Approved: September 5, 2017

• Actelion Receives FDA Approval of Tracleer (bosentan) for Use in Pediatric Patients with Pulmonary Arterial Hypertension

Afluria (influenza virus vaccine)

Patient Population Altered: August 31, 2017

• Seqirus Receives FDA Approval of Afluria Quadrivalent (Influenza Vaccine) for People Five Years of Age and Older in the U.S.
• Afluria (influenza virus vaccine) FDA Approval History

Aptiom (eslicarbazepine acetate)

Patient Population Altered: September 13, 2017

• Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older
• Aptiom (eslicarbazepine acetate) FDA Approval History

Privigen (immune globulin intravenous (human))

New Indication Approved: September 14, 2017

• CSL Behring Announces FDA Approval of Privigen [Immune Globulin Intravenous (Human), 10% Liquid] for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Adults
• Privigen (immune globulin intravenous (human)) FDA Approval History

Aliqopa (copanlisib) Injection

Date of Approval: September 14, 2017
Company: Bayer Healthcare Pharmaceuticals, Inc.
Treatment for: Follicular Lymphoma

Aliqopa (copanlisib) is a phosphatidylinositol-3-kinase (PI3K) inhibitor indicated for the treatment of adult patients with relapsed follicular lymphoma (FL).

• FDA Approves Aliqopa (copanlisib) for Adults with Relapsed Follicular Lymphoma
• Aliqopa (copanlisib) FDA Approval History

Mvasi (bevacizumab-awwb) Injection

Date of Approval: September 14, 2017
Company: Amgen Inc.
Treatment for: Non-Small Cell Lung Cancer, Colorectal Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer

Mvasi (bevacizumab-awwb) is an anti-vascular endothelial growth factor A (anti-VEGF) monoclonal antibody biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, and cervical cancer.

• FDA Approves Mvasi (bevacizumab-awwb), a Biosimilar to Avastin
• Mvasi (bevacizumab-awwb) FDA Approval History

Briviact (brivaracetam)

New Indication Approved: September 14, 2017

• FDA Approves New indication for Briviact (brivaracetam) as Monotherapy Treatment of Partial-Onset Seizures in Adults
• Briviact (brivaracetam) FDA Approval History

Adzenys ER (amphetamine) Extended-Release Liquid Suspension - formerly NT-0201

Date of Approval: September 15, 2017
Company: Neos Therapeutics, Inc.
Treatment for: Attention-Deficit Hyperactivity Disorder (ADHD)

Adzenys ER (amphetamine) is an extended-release liquid suspension formulation of the central nervous system (CNS) stimulant amphetamine indicated for the treatment of ADHD in patients 6 years and older.

• Neos Therapeutics Receives U.S. FDA Approval of Adzenys ER (amphetamine) Extended-Release Oral Suspension for ADHD
• Adzenys ER (amphetamine) FDA Approval History

Somatuline Depot (lanreotide acetate)

New Indication Approved: September 15, 2017
Treatment for: Acromegaly; Gastroenteropancreatic Neuroendocrine Tumors; Carcinoid Syndrome

• FDA Approves New Indication for Ipsen’s Somatuline Depot (lanreotide) Injection for the Treatment of Carcinoid Syndrome
• Somatuline Depot (lanreotide acetate) FDA Approval History

Solosec (secnidazole) Oral Granules

Date of Approval: September 15, 2017
Company: Symbiomix Therapeutics, LLC
Treatment for: Bacterial Vaginosis

Solosec (secnidazole) is a nitroimidazole antimicrobial for use as a single-dose oral therapy in the treatment of bacterial vaginosis (BV).

• FDA Approves Symbiomix Therapeutics’ Solosec (secnidazole) Oral Granules for the Treatment of Bacterial Vaginosis in Adult Women
• Solosec (secnidazole) FDA Approval History

Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) Inhalation Powder

Date of Approval: September 18, 2017
Company: GlaxoSmithKline
Treatment for: Chronic Obstructive Pulmonary Disease

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is an inhaled corticosteroid, long-acting muscarinic antagonist (LAMA) and long-acting beta₂-adrenergic agonist (LABA) combination for the treatment of patients with chronic obstructive pulmonary disease (COPD).

• FDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of COPD
• Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) FDA Approval History

Xhance (fluticasone propionate) Nasal Spray - formerly OPN-375

Date of Approval: September 18, 2017
Company: OptiNose US Inc.
Treatment for: Nasal Polyps

Xhance (fluticasone propionate) is a topical nasal corticosteroid indicated for the treatment of nasal polyps.

• Optinose Announces FDA Approval of Xhance (fluticasone propionate) Nasal Spray for the Treatment of Nasal Polyps
• Xhance (fluticasone propionate) FDA Approval History

Rapivab (peramivir)

Patient Population Altered: September 20, 2017

• BioCryst's Rapivab (peramivir injection) Receives FDA Approval for a Pediatric Indication
• Rapivab (peramivir) FDA Approval History

Opdivo (nivolumab)

New Indication Approved: September 22, 2017

• Bristol-Myers Squibb’s Opdivo (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib
• Opdivo (nivolumab) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: September 22, 2017

• FDA Approves Merck’s Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1
• Keytruda (pembrolizumab) FDA Approval History

Verzenio (abemaciclib) Tablets

Date of Approval: September 28, 2017
Company: Eli Lilly and Company
Treatment for: Breast Cancer

Verzenio (abemaciclib) is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

• FDA Approves Verzenio (abemaciclib) for Certain Advanced or Metastatic Breast Cancers
• Verzenio (abemaciclib) FDA Approval History

Fiasp (insulin aspart) Injection

Date of Approval: September 29, 2017
Company: Novo Nordisk
Treatment for: Diabetes Type 1, Diabetes Type 2

Fiasp (insulin aspart) is a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Fiasp is a new formulation of NovoLog, in which the addition of niacinamide (vitamin B3) helps to increase the speed of the initial insulin absorption.

• Novo Nordisk Receives FDA Approval for Fiasp (insulin aspart injection), a New Fast-Acting Mealtime Insulin
• Fiasp (insulin aspart) FDA Approval History

Verzenio (abemaciclib)

New Indication Approved: February 26, 2018

• Lilly Receives Additional FDA Approval for Verzenio (abemaciclib), as Initial Treatment for Advanced Breast Cancer
• Verzenio (abemaciclib) FDA Approval History

Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) Inhalation Powder

Date of Approval: September 18, 2017
Company: GlaxoSmithKline
Treatment for: Chronic Obstructive Pulmonary Disease

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is an inhaled corticosteroid, long-acting muscarinic antagonist (LAMA) and long-acting beta₂-adrenergic agonist (LABA) combination for the treatment of patients with chronic obstructive pulmonary disease (COPD).

• Once-Daily Trelegy Ellipta Gains Expanded Indication in the US for the Treatment of Patients with COPD
• Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) FDA Approval History