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New Drug Approvals Archive - 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 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.

Read more: 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).

Read more: Aliqopa (copanlisib) FDA Approval History

Mvasi (bevacizumab-awwb) Injection - formerly ABP 215

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.

Read more: 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.

Read more: Adzenys ER (amphetamine) FDA Approval History

Somatuline Depot (lanreotide acetate)

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

Read more: 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).

Read more: 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).

Read more: 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.

Read more: 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 for the treatment of metastatic breast cancer.

Read more: 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.

Read more: Fiasp (insulin aspart) FDA Approval History

New Drug Approvals Archive