New Drug Approvals Archive - December 2014

Bellafill (dermal filler)

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

• Bellafill to Replace ArteFill as New Brand

Bellafill (dermal filler) FDA Approval History

Priftin (rifapentine)

New Indication Approved: November 25, 2014

• Sanofi Receives FDA Approval of Priftin (rifapentine) for Latent Tuberculosis Infection

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.

• FDA Approves PulmoFlow's Kitabis Pak Tobramycin & Nebulizer Combination for Cystic Fibrosis

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).

• FDA Approves Blincyto (blinatumomab) for Precursor B-Cell Acute Lymphoblastic Leukemia

Blincyto (blinatumomab) FDA Approval History

Jakafi (ruxolitinib)

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

• FDA Approves Jakafi (ruxolitinib) for Polycythemia Vera

Jakafi (ruxolitinib) FDA Approval History

Abilify Maintena (aripiprazole)

Labeling Revision Approved: December 5, 2014

• FDA Approves Labeling Update Of Abilify Maintena for Acutely Relapsed Adults With Schizophrenia

Abilify Maintena (aripiprazole) FDA Approval History

Xgeva (denosumab)

New Indication Approved: December 5, 2014

• FDA Approves Xgeva (denosumab) for Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy

Xgeva (denosumab) 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.

• FDA Approves Gardasil 9 for Prevention of Certain Cancers Caused by Five Additional Types of HPV

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

Cyramza (ramucirumab)

New Indication Approved: December 12, 2014

• FDA Expands Approved use of Cyramza to Treat Aggressive Non-Small Cell Lung Cancer

Cyramza (ramucirumab) FDA Approval History

Zubsolv (buprenorphine and naloxone)

New Dosage Form Approved: December 11, 2014

• FDA Approves Two Higher Dosage Strengths of Zubsolv

Zubsolv (buprenorphine and naloxone) FDA Approval History

Fluzone (influenza virus vaccine, inactivated)

New Formulation Approved: December 12, 2014

• Sanofi Pasteur Announces FDA Approval Of Fluzone Intradermal Quadrivalent

Somatuline Depot (lanreotide acetate)

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

• FDA Approves Somatuline Depot (lanreotide) for Gastroenteropancreatic Neuroendocrine Tumors

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.

• Novartis Gains FDA Approval for Signifor LAR to Treat Patients with Acromegaly

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.

• FDA Approves Xtoro (finafloxacin) Otic Suspension to Treat Swimmer’s Ear

Xtoro (finafloxacin) FDA Approval History

QNASL (beclomethasone dipropionate)

New Formulation Approved: December 17, 2014

• Teva Announces FDA Approval of QNASL for Children with Seasonal and Perennial Allergic Rhinitis

QNASL (beclomethasone dipropionate) FDA Approval History

Lynparza (olaparib) Capsules

Date of Approval: December 19, 2014
Company: AstraZeneca
Treatment for: Ovarian Cancer

Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor for the treatment of advanced ovarian cancer.

• FDA Approves Lynparza (olaparib) to Treat Advanced Ovarian Cancer

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.

• FDA Approves Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) to Treat Hepatitis C

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

Erwinaze (asparaginase Erwinia chrysanthemi)

New Dosage Regimen: December 19, 2014

• Jazz Pharmaceuticals Receives FDA Approval For Intravenous Administration Of Erwinaze

Erwinaze (asparaginase Erwinia chrysanthemi) 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).

• FDA Approves Zerbaxa (ceftolozane/tazobactam) for Complicated Intra-Abdominal/Urinary Tract Infections

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

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, and urothelial carcinoma.

• FDA Approves Opdivo (nivolumab) for Advanced Melanoma

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 in adults.

• FDA Approves Rapivab (peramivir) to Treat Influenza Infection

Rapivab (peramivir) FDA Approval History

Granix (tbo-filgrastim)

New Dosage Regimen: December 19, 2014

• FDA Approves Teva’s Granix (tbo-filgrastim) Injection for Self-Administration

Granix (tbo-filgrastim) 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.

• Galderma Receives FDA Approval of Soolantra (ivermectin) Cream for Rosacea

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.

• FDA Approves Saxenda (liraglutide [rDNA origin] injection) for Obesity

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.

• Actavis and Adamas Announce FDA Approval of Namzaric (memantine/donepezil) for Alzheimer's Disease

Namzaric (donepezil and memantine) FDA Approval History

Kalydeco (ivacaftor)

New Indication Approved: December 29, 2014

• FDA Approves Kalydeco (ivacaftor) for Use in People with Cystic Fibrosis Ages 6 and Older Who Have the R117H Mutation

Kalydeco (ivacaftor) 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.

• Hospira Receives U.S. FDA Approval of Proprietary Analgesic Dyloject (diclofenac sodium) Injection

Dyloject (diclofenac sodium) FDA Approval History

Opdivo (nivolumab)

New Indication Approved: March 4, 2015

• FDA Expands Approved use of Opdivo (nivolumab) to Treat Lung Cancer

Opdivo (nivolumab) FDA Approval History

Opdivo (nivolumab)

New Dosage Regimen: September 30, 2015

• BMS Receives FDA Approval for Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Melanoma

Opdivo (nivolumab) FDA Approval History

Opdivo (nivolumab)

Labeling Revision Approved: October 9, 2015

• FDA Expands Approved Use of Opdivo (nivolumab) in Advanced Lung Cancer

Opdivo (nivolumab) FDA Approval History

Opdivo (nivolumab)

New Indication Approved: November 23, 2015

• FDA Approves Opdivo to Treat Metastatic Renal Cell Carcinoma

Opdivo (nivolumab) 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

Opdivo (nivolumab)

New Indication Approved: January 23, 2016

• Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status

Opdivo (nivolumab) FDA Approval History

Opdivo (nivolumab)

New Indication Approved: May 17, 2016

• Opdivo (nivolumab) FDA Approved for the Treatment of Hodgkin Lymphoma

Opdivo (nivolumab) FDA Approval History

Blincyto (blinatumomab)

Patient Population Altered: August 30, 2016

• FDA Approves Blincyto (blinatumomab) For Use In Pediatric Patients With Philadelphia Chromosome-Negative Relapsed Or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Blincyto (blinatumomab) FDA Approval History

Opdivo (nivolumab)

New Indication Approved: November 10, 2016

• Bristol-Myers Squibb’s Opdivo (nivolumab) is the First Immuno-Oncology Treatment to Receive FDA Approval Based on Overall Survival in Head and Neck Cancer

Opdivo (nivolumab) FDA Approval History

Opdivo (nivolumab)

New Indication Approved: February 2, 2017

• Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma

Opdivo (nivolumab) FDA Approval History

Blincyto (blinatumomab)

New Indication Approved: July 11, 2017

• FDA Grants Full Approval for Blincyto (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children

Blincyto (blinatumomab) FDA Approval History