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New Drug Approvals Archive - May 2014

See also: New Indications and Dosage Forms for May 2014

May 2014

Epanova (omega-3-carboxylic acids) Capsules

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

Marketing Status: Discontinued

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

Zontivity (vorapaxar) Tablets

Date of Approval: May 8, 2014
Company: Merck
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.

Entyvio (vedolizumab) Injection

Date of Approval: May 20, 2014
Company: Takeda Pharmaceutical Company Limited
Treatment for: Crohn's Disease -- Acute, Ulcerative Colitis

Entyvio (vedolizumab) is an integrin receptor antagonist for the treatment of Crohn's disease and ulcerative colitis.

Dalvance (dalbavancin) Injection

Date of Approval: May 23, 2014
Company: Allergan, Inc.
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).

Natesto (testosterone) Intranasal Gel - formerly CompleoTRT

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

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

Omidria (ketorolac and phenylephrine) Injection

Date of Approval: May 30, 2014
Company: Omeros Corporation
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.

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