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:

• treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older.
• treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older.

• FDA Approves Mylotarg (gemtuzumab ozogamicin) for the Treatment of Acute Myeloid Leukemia
• Mylotarg (gemtuzumab ozogamicin) 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, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal 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; cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

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

Solosec (secnidazole) Oral Granules

Date of Approval: September 15, 2017
Company: Lupin Pharmaceuticals, Inc.
Treatment for: Bacterial Vaginosis, Trichomoniasis

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

• 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: COPD, Asthma, Maintenance

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is an inhaled corticosteroid, long-acting muscarinic antagonist (LAMA), and long-acting beta₂-adrenergic agonist (LABA) combination indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), and the maintenance treatment of asthma in patients aged 18 years and older.

• 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

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 used for the treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2 negative (HR+ HER2-) 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 and children with diabetes mellitus. Fiasp is a newer formulation of NovoLog, in which the addition of niacinamide (vitamin B3) helps to increase the speed of 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

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

Date of Approval: September 18, 2017
Company: GlaxoSmithKline
Treatment for: COPD, Asthma, Maintenance

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is an inhaled corticosteroid, long-acting muscarinic antagonist (LAMA), and long-acting beta₂-adrenergic agonist (LABA) combination indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), and the maintenance treatment of asthma in patients aged 18 years and older.

• 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