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New Drug Approvals Archive - December 2015

See also: New Indications and Dosage Forms for December 2015

December 2015

QuilliChew ER (methylphenidate hydrochloride) Extended Release Chewable Tablets

Date of Approval: December 7, 2015
Company: Pfizer Inc.
Treatment for: Attention Deficit Hyperactivity Disorder

QuilliChew ER (methylphenidate hydrochloride) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Vonvendi (von willebrand factor (recombinant)) for Injection

Date of Approval: December 8, 2015
Company: Baxalta Incorporated
Treatment for: von Willebrand's Disease

Vonvendi [von Willebrand factor (recombinant)] is a recombinant von Willebrand factor (VWF) indicated for on-demand treatment and control of bleeding episodes in adults diagnosed with von Willebrand disease.

Kanuma (sebelipase alfa) Injection

Date of Approval: December 8, 2015
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Lysosomal Acid Lipase Deficiency

Kanuma (sebelipase alfa) is an enzyme replacement therapy for the treatment of lysosomal acid lipase deficiency (LAL-D).

Bendeka (bendamustine hydrochloride) Injection

Date of Approval: December 7, 2015
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Chronic Lymphocytic Leukemia, non-Hodgkin's Lymphoma

Bendeka (bendamustine hydrochloride) is an alkylating drug indicated for treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Otiprio (ciprofloxacin) Otic Suspension - formerly AuriPro

Date of Approval: December 10, 2015
Company: Otonomy, Inc.
Treatment for: Tympanostomy Tube Placement Surgery; Acute Otitis Externa

Otiprio (ciprofloxacin otic suspension) is a single-dose, physician-administered, sustained-exposure otic fluoroquinolone antibacterial for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery, and for the treatment of acute otitis externa due to Pseudomonas aeruginosa and Staphylococcus aureus.

Vistogard (uridine triacetate) Oral Granules

Date of Approval: December 11, 2015
Company: Wellstat Therapeutics Corporation
Treatment for: Fluorouracil Overdose and Capecitabine Overdose

Vistogard (uridine triacetate) is a pyrimidine analog indicated for the emergency treatment of adults and children who receive an overdose of the cancer treatments fluorouracil or capecitabine.

Alecensa (alectinib) Capsules

Date of Approval: December 11, 2015
Company: Genentech, Inc.
Treatment for: Non-Small Cell Lung Cancer

Alecensa (alectinib) is an oral, anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive non-small cell lung cancer (NSCLC).

Bridion (sugammadex) Injection

Date of Approval: December 15, 2015
Company: Merck & Co., Inc.
Treatment for: Reversal of Nondepolarizing Muscle Relaxants

Bridion (sugammadex) is a novel selective relaxant binding agent (SRBA) for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

Basaglar (insulin glargine) Injection

Date of Approval: December 16, 2015
Company: Eli Lilly and Company and Boehringer Ingelheim
Treatment for: Diabetes Type 1, Diabetes Type 2

Basaglar (insulin glargine injection) is a long-acting human insulin analog indicated to improve glycemic control in patients with type 1 and type 2 diabetes mellitus.

Zurampic (lesinurad) Tablets

Date of Approval: December 22, 2015
Company: Ironwood Pharmaceuticals, Inc.
Treatment for: Hyperuricemia Associated with Gout

Marketing Status: Discontinued

Zurampic (lesinurad) is a URAT1 inhibitor indicated for the combination treatment of hyperuricemia associated with gout.

Uptravi (selexipag) Tablets

Date of Approval: December 21, 2015
Company: Actelion Pharmaceuticals US, Inc.
Treatment for: Pulmonary Arterial Hypertension

Uptravi (selexipag) is an oral prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension.

Docetaxel Non-Alcohol Formula () Injection

Date of Approval: December 22, 2015
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Cancer

Docetaxel Injection, Non-Alcohol Formula is an alcohol-free formulation of docetaxel for use in the treatment of patients with breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

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