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New Drug Approvals Archive - December 2014

December 2014

Bellafill (dermal filler)

New Dosage Form Approved: December 1, 2014
Treatment for: Facial Wrinkles; Acne Scars

Read more: Bellafill (dermal filler) FDA Approval History

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.

Read more: Kitabis Pak (tobramycin) FDA Approval History

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.

Read more: Blincyto (blinatumomab) FDA Approval History

Jakafi (ruxolitinib)

New Indication Approved: December 4, 2014
Treatment for: Myelofibrosis; Polycythemia Vera

Read more: Jakafi (ruxolitinib) FDA Approval History

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.

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

Zubsolv (buprenorphine and naloxone)

New Dosage Form Approved: December 11, 2014

Read more: Zubsolv (buprenorphine and naloxone) FDA Approval History

Fluzone (influenza virus vaccine, inactivated)

New Formulation Approved: December 12, 2014

Somatuline Depot (lanreotide acetate)

New Indication Approved: December 16, 2014
Treatment for: Acromegaly; Gastroenteropancreatic Neuroendocrine Tumors; Carcinoid Syndrome

Read more: Somatuline Depot (lanreotide acetate) FDA Approval History

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.

Read more: Signifor LAR (pasireotide) FDA Approval History

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.

Read more: Xtoro (finafloxacin) FDA Approval History

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.

Read more: Lynparza (olaparib) FDA Approval History

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.

Read more: Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) FDA Approval History

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).

Read more: Zerbaxa (ceftolozane and tazobactam) FDA Approval History

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

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 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.

Read more: Opdivo (nivolumab) FDA Approval History

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.

Read more: Rapivab (peramivir) FDA Approval History

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.

Read more: Soolantra (ivermectin) FDA Approval History

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.

Read more: Saxenda (liraglutide) FDA Approval History

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.

Read more: Namzaric (donepezil and memantine) FDA Approval History

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.

Read more: Dyloject (diclofenac sodium) FDA Approval History

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

Patient Population Altered: December 15, 2015

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

New Drug Approvals Archive