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New Drug Approvals Archive - December 2014

See also: New Indications and Dosage Forms for December 2014

December 2014

Kitabis Pak (tobramycin) Inhalation Solution

Date of Approval: December 2, 2014
Company: PulmoFlow, Inc.
Treatment for: Cystic Fibrosis

Kitabis Pak (tobramycin) is an aminoglycoside inhalation solution co-packaged with a PARI LC PLUS® Reusable Nebulizer for the management of cystic fibrosis.

Blincyto (blinatumomab) Injection

Date of Approval: December 3, 2014
Company: Amgen Inc.
Treatment for: Acute Lymphoblastic Leukemia

Blincyto (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), and minimal residual disease (MRD)-positive B-cell precursor ALL.

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

Date of Approval: December 10, 2014
Company: Merck & Co., Inc.
Treatment for: Human Papillomavirus Prophylaxis

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) is a 9-valent HPV vaccine for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.

Signifor LAR (pasireotide) for Injectable Suspension

Date of Approval: December 15, 2014
Company: Novartis
Treatment for: Acromegaly

Signifor LAR (pasireotide) is a long acting a somatostatin analog formulation for the treatment of patients with acromegaly.

Xtoro (finafloxacin) Otic Suspension

Date of Approval: December 17, 2014
Company: Alcon Laboratories, Inc.
Treatment for: Otitis Externa

Xtoro (finafloxacin otic suspension) is a fluoroquinolone antimicrobial for the treatment of acute otitis externa, commonly known as swimmer’s ear.

Lynparza (olaparib) Capsules and Tablets

Date of Approval: December 19, 2014
Company: AstraZeneca
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Breast Cancer

Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor for the treatment of BRCA-mutated, advanced ovarian cancer; for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer; and for the treatment of germline BRCA-mutated metastatic breast cancer.

Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) Tablets

Date of Approval: December 19, 2014
Company: AbbVie Inc.
Treatment for: Chronic Hepatitis C

Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) is an NS5A inhibitor, NS3/4A protease inhibitor and CYP3A inhibitor combination co-packaged with a non-nucleoside NS5B palm polymerase inhibitor for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection.

Zerbaxa (ceftolozane and tazobactam) Injection

Date of Approval: December 19, 2014
Company: Cubist Pharmaceuticals, Inc.
Treatment for: Intraabdominal Infection, Urinary Tract Infection

Zerbaxa (ceftolozane and tazobactam) is a cephalosporin and beta-lactamase inhibitor combination for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).

Opdivo (nivolumab) Injection

Date of Approval: December 22, 2014
Company: Bristol-Myers Squibb Company
Treatment for: Melanoma - Metastatic, Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Hodgkin's Disease, Head and Neck Cancer, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Small Cell Lung Cancer

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, and hepatocellular carcinoma.

Rapivab (peramivir) Injection

Date of Approval: December 19, 2014
Company: BioCryst Pharmaceuticals, Inc.
Treatment for: Influenza

Rapivab (peramivir) is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza.

Soolantra (ivermectin) Cream

Date of Approval: December 19, 2014
Company: Galderma Laboratories, L.P.
Treatment for: Acne Rosacea

Soolantra (ivermectin) is a topical antiparasitic with anti-inflammatory properties for the treatment of rosacea potentially caused by the microscopic skin mite Demodex folliculorum.

Saxenda (liraglutide) Injection

Date of Approval: December 23, 2014
Company: Novo Nordisk Inc.
Treatment for: Obesity

Saxenda (liraglutide) is a once-daily glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity.

Namzaric (donepezil and memantine)

Date of Approval: December 23, 2014
Company: Allergan, Inc.
Treatment for: Alzheimer's Disease

Namzaric (memantine hydrochloride extended-release and donepezil hydrochloride) is an NMDA receptor antagonist and acetylcholinesterase inhibitor fixed-dose combination for the treatment of moderate to severe Alzheimer’s disease.

Dyloject (diclofenac sodium) Injection

Date of Approval: December 23, 2014
Company: Javelin Pharmaceuticals, Inc.
Treatment for: Pain

Dyloject (diclofenac sodium injection) is an intravenous non-steroidal anti-inflammatory drug (NSAID) for the management of acute moderate-to-severe pain in adults.

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