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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Ruconest (C1 esterase inhibitor (recombinant)) - formerly Rhucin

Company: Pharming Group NV
Date of Approval: July 16, 2014
Treatment for: Angioedema

Ruconest is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

Ruconest FDA Approval History

Rasuvo (methotrexate) - formerly MPI-2505

Company: Medac Pharma, Inc.
Date of Approval: July 11, 2014
Treatment for: Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Psoriasis

Rasuvo (methotrexate) is a subcutaneous, ready-to-use autopen formulation of methotrexate for the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.

Rasuvo FDA Approval History

Kerydin (tavaborole) Topical Solution

Company: Anacor Pharmaceuticals
Date of Approval: July 7, 2014
Treatment for: Onychomycosis -- Toenail

Kerydin (tavaborole) is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails.

Kerydin FDA Approval History

Beleodaq (belinostat) Injection

Company: Spectrum Pharmaceuticals, Inc.
Date of Approval: July 3, 2014
Treatment for: Peripheral T-cell Lymphoma

Beleodaq (belinostat) is a histone deacetylase (HDAC) inhibitor for the treatment of peripheral T-cell lymphoma (PTCL).

Beleodaq FDA Approval History

Afrezza (insulin human [rDNA origin]) Inhalation Powder - formerly Afresa

Company: MannKind Corporation
Date of Approval: June 27, 2014
Treatment for: Diabetes Type 1, Diabetes Type 2

Afrezza (insulin human [rDNA origin]) is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.

Afrezza FDA Approval History

Vazculep (phenylephrine hydrochloride) Injection

Company: Flamel Technologies
Date of Approval: June 27, 2014
Treatment for: Hypotension

Vazculep (phenylephrine hydrochloride) injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of hypotension resulting primarily from vasodilation in the setting of anesthesia.

Vazculep FDA Approval History

Sivextro (tedizolid phosphate) Tablets and Injection

Company: Cubist Pharmaceuticals, Inc.
Date of Approval: June 20, 2014
Treatment for: Skin and Structure Infection

Sivextro (tedizolid phosphate) is an oxazolidinone antibiotic drug indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Sivextro FDA Approval History

Jublia (efinaconazole) Topical Solution

Company: Valeant Pharmaceuticals International, Inc.
Date of Approval: June 6, 2014
Treatment for: Onychomycosis -- Toenail

Jublia (efinaconazole) is a topical triazole antifungal for the treatment of onychomycosis of the toenails.

Jublia FDA Approval History

Bunavail (buprenorphine and naloxone) Buccal Film

Company: BioDelivery Sciences International, Inc.
Date of Approval: June 6, 2014
Treatment for: Opiate Dependence

Bunavail (buprenorphine and naloxone) buccal film is an opioid analgesic/opioid antagonist formulation for the maintenance treatment of opioid dependence.

Bunavail FDA Approval History

Eloctate (antihemophilic factor (recombinant)) for Injection

Company: Biogen Idec, Inc.
Date of Approval: June 6, 2014
Treatment for: Hemophilia A

Eloctate (antihemophilic factor (recombinant ) Fc Fusion Protein is a recombinant DNA derived, antihemophilic factor indicated for the treatment of patients with Hemophilia A.

Eloctate FDA Approval History

Vogelxo (testosterone) Transdermal Gel

Company: Upsher-Smith Laboratories, Inc.
Date of Approval: June 4, 2014
Treatment for: Hypogonadism -- Male

Vogelxo (testosterone) transdermal gel is an androgen indicated for testosterone replacement therapy in males with hypogonadism.

Vogelxo FDA Approval History

Omidria (ketorolac and phenylephrine) Injection

Company: Omeros Corporation
Date of Approval: May 30, 2014
Treatment for: Intraocular Lens Replacement Procedures

Omidria (ketorolac and phenylephrine) is an anti-inflammatory and mydriatic combination added to irrigation solution during cataract surgery and intraocular lens replacement procedures.

Omidria FDA Approval History

Natesto (testosterone) Intranasal Gel - formerly CompleoTRT

Company: Trimel Pharmaceuticals Corporation
Date of Approval: May 28, 2014
Treatment for: Hypogonadism -- Male

Natesto (testosterone) is a bioadhesive intranasal gel testosterone product for the treatment of male hypogonadism.

Natesto FDA Approval History

Dalvance (dalbavancin) Injection

Company: Durata Therapeutics, Inc.
Date of Approval: May 23, 2014
Treatment for: Skin and Structure Infection

Dalvance (dalbavancin) is a second generation lipoglycopeptide antibiotic for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

Dalvance FDA Approval History

Zontivity (vorapaxar) Tablets

Company: Merck
Date of Approval: May 8, 2014
Treatment for: Cardiovascular Risk Reduction

Zontivity (vorapaxar) is a protease-activated receptor-1 (PAR-1) antagonist for the prevention of cardiovascular events in high risk patients.

Zontivity FDA Approval History

Epanova (omega-3-carboxylic acids) Capsules

Company: AstraZeneca
Date of Approval: May 5, 2014
Treatment for: Hypertriglyceridemia

Epanova (omega-3-carboxylic acids) is a fish oil-derived mixture of free fatty acids for the treatment of patients with severe hypertriglyceridemia.

Epanova FDA Approval History

Incruse Ellipta (umeclidinium) Inhalation Powder

Company: GlaxoSmithKline
Date of Approval: April 30, 2014
Treatment for: Chronic Obstructive Pulmonary Disease -- Maintenance

Incruse Ellipta (umeclidinium) is an anticholinergic bronchodilator indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

Incruse Ellipta FDA Approval History

Zykadia (ceritinib) Capsules

Company: Novartis Pharmaceuticals Corporation
Date of Approval: April 29, 2014
Treatment for: Non-Small Cell Lung Cancer

Zykadia (ceritinib) is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer.

Zykadia FDA Approval History

Purixan (mercaptopurine) Oral Suspension

Company: Nova Laboratories, Ltd.
Date of Approval: April 28, 2014
Treatment for: Acute Lymphoblastic Leukemia

Purixan (mercaptopurine) is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia.

Purixan FDA Approval History
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