New Drug Approvals Archive - 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).

• Pfizer Receives FDA Approval for QuilliChew ER (methylphenidate hydrochloride) Extended-Release Chewable Tablets

QuilliChew ER (methylphenidate hydrochloride) FDA Approval History

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.

• FDA Approves Vonvendi (Von Willebrand Factor (Recombinant)) to Treat Bleeding Episodes in Patients with VWD

Vonvendi (von willebrand factor (recombinant)) FDA Approval History

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).

• FDA Approves Kanuma (sebelipase alfa) for Lysosomal Acid Lipase Deficiency

Kanuma (sebelipase alfa) FDA Approval History

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.

• Teva Pharmaceuticals and Eagle Pharmaceuticals Announce FDA Approval of Bendeka (bendamustine hydrochloride) Injection

Bendeka (bendamustine hydrochloride) FDA Approval History

Otiprio (ciprofloxacin) Otic Suspension - formerly AuriPro

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

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.

• FDA Approves Otiprio (ciprofloxacin otic suspension) for the Treatment of Pediatric Patients Undergoing Tympanostomy Tube Placement Surgery

Otiprio (ciprofloxacin) FDA Approval History

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.

• FDA Approves Vistogard (uridine triacetate) for Emergency Treatment for Overdose of Certain Types of Chemotherapy

Vistogard (uridine triacetate) FDA Approval History

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 people with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

• FDA Approves Alecensa (alectinib) for ALK-Positive Non-Small Cell Lung Cancer

Alecensa (alectinib) FDA Approval History

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)

Patient Population Altered: December 15, 2015

• FDA Approves Expanded Age Indication for Gardasil 9 in Males

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) FDA Approval History

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.

• FDA Approves Bridion (sugammadex) to Reverse Effects of Neuromuscular Blocking Drugs

Bridion (sugammadex) FDA Approval History

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.

• FDA Approves Basaglar (insulin glargine) for Type 1 and Type 2 Diabetes

Basaglar (insulin glargine) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: December 18, 2015

• FDA Approves Expanded Indication for Keytruda (pembrolizumab) for the Treatment of Patients with Advanced Melanoma

Keytruda (pembrolizumab) FDA Approval History

Zurampic (lesinurad) Tablets

Date of Approval: December 22, 2015
Company: AstraZeneca Pharmaceuticals LP
Treatment for: Hyperuricemia Associated with Gout

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

• FDA Approves Zurampic (lesinurad) to Treat High Blood Uric Acid Levels Associated with Gout

Zurampic (lesinurad) FDA Approval History

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.

• FDA Approves Uptravi (selexipag) for Pulmonary Arterial Hypertension

Uptravi (selexipag) FDA Approval History

Xeomin (incobotulinumtoxinA)

New Indication Approved: December 22, 2015

• Merz North America Announces FDA Approval of Xeomin (incobotulinumtoxinA) for Treatment of Adult Upper Limb Spasticity

Xeomin (incobotulinumtoxinA) FDA Approval History

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.

• Teikoku Pharma USA, Inc. Announces FDA Approval of Docetaxel Injection, Non-Alcohol Formula

Docetaxel Non-Alcohol Formula FDA Approval History