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New Drug Approvals Archive - September 2017

See also: New Indications and Dosage Forms for September 2017

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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