New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

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Natpara (recombinant human parathyroid hormone)

Company: NPS Pharmaceuticals, Inc.
Date of Approval: January 23, 2015
Treatment for: Hypoparathyroidism

Natpara (recombinant human parathyroid hormone) is a bioengineered replica of human parathyroid hormone 1-84 to control hypocalcemia in patients with hypoparathyroidism.

Natpara FDA Approval History

Bexsero (meningococcal group B vaccine)

Company: Novartis Vaccines and Diagnostics Inc.
Date of Approval: January 23, 2015
Treatment for: Meningitis -- Meningococcal

Bexsero (meningococcal group B vaccine) is a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

Bexsero FDA Approval History

Cosentyx (secukinumab)

Company: Novartis Pharmaceuticals Corporation
Date of Approval: January 21, 2015
Treatment for: Plaque Psoriasis

Cosentyx (secukinumab) is a selective interleukin-17A (IL-17A) inhibitor for the treatment of moderate-to-severe plaque psoriasis.

Cosentyx FDA Approval History

Prestalia (amlodipine besylate and perindopril arginine) Tablets

Company: Symplmed
Date of Approval: January 21, 2015
Treatment for: Hypertension

Prestalia (amlodipine besylate and perindopril arginine) is a calcium channel blocker and long-acting angiotensin-converting enzyme (ACE) inhibitor combination for the treatment of hypertension.

Prestalia FDA Approval History

Phoxillum (renal replacement solution)

Company: Baxter International Inc.
Date of Approval: January 13, 2015
Treatment for: Continuous Renal Replacement Therapy

Phoxillum (renal replacement solution) is a replacement solution used for electrolyte management in Continuous Renal Replacement Therapy (CRRT).

Phoxillum FDA Approval History

Duopa (carbidopa and levodopa) Enteral Suspension

Company: AbbVie Inc.
Date of Approval: January 12, 2015
Treatment for: Parkinson's Disease

Duopa (carbidopa and levodopa) is an aromatic amino acid decarboxylation inhibitor and aromatic amino acid combination formulated as an enteral suspension for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.

Duopa FDA Approval History

Savaysa (edoxaban) Tablets

Company: Daiichi Sankyo Company
Date of Approval: January 8, 2015
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism

Savaysa (edoxaban) is an oral, once-daily factor Xa inhibitor anticoagulant indicated for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the treatment of deep vein thrombosis, and pulmonary embolism.

Savaysa FDA Approval History

Rytary (carbidopa and levodopa) Extended Release Capsules - formerly IPX066

Company: Impax Laboratories, Inc.
Date of Approval: January 7, 2015
Treatment for: Parkinson's Disease

Rytary (carbidopa and levodopa) is an extended release aromatic amino acid decarboxylation inhibitor and aromatic amino acid combination indicated for the treatment of Parkinson’s disease.

Rytary FDA Approval History

Saxenda (liraglutide) Injection

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

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

Saxenda FDA Approval History

Namzaric (donepezil and memantine)

Company: Actavis plc and Adamas Pharmaceuticals Inc.
Date of Approval: December 23, 2014
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.

Namzaric FDA Approval History

Dyloject (diclofenac sodium) Injection

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

Dyloject FDA Approval History

Lynparza (olaparib) Capsules

Company: AstraZeneca
Date of Approval: December 19, 2014
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.

Lynparza FDA Approval History

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

Company: AbbVie Inc.
Date of Approval: December 19, 2014
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.

Viekira Pak FDA Approval History

Zerbaxa (ceftolozane and tazobactam) Injection

Company: Cubist Pharmaceuticals, Inc.
Date of Approval: December 19, 2014
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).

Zerbaxa FDA Approval History

Rapivab (peramivir) Injection

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

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

Rapivab FDA Approval History

Soolantra (ivermectin) Cream

Company: Galderma Laboratories, L.P.
Date of Approval: December 19, 2014
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.

Soolantra FDA Approval History

Xtoro (finafloxacin) Otic Suspension

Company: Alcon Laboratories, Inc.
Date of Approval: December 17, 2014
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.

Xtoro FDA Approval History

Signifor LAR (pasireotide) for Injectable Suspension

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

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

Signifor LAR FDA Approval History

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

Company: Merck & Co., Inc.
Date of Approval: December 10, 2014
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.

Gardasil 9 FDA Approval History
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