Skip to Content

New Drug Approvals Archive - May 2014

May 2014

May 5

Epanova (omega-3-carboxylic acids) Capsules

Date of Approval: May 5, 2014
Company: AstraZeneca
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 (omega-3-carboxylic acids) FDA Approval History

May 8

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.

Zontivity (vorapaxar) FDA Approval History

May 20

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.

Entyvio (vedolizumab) FDA Approval History

May 23

Vectibix (panitumumab)

New Indication Approved: May 23, 2014

Vectibix (panitumumab) FDA Approval History

May 23

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).

Dalvance (dalbavancin) FDA Approval History

May 28

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.

Natesto (testosterone) FDA Approval History

May 30

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.

Omidria (ketorolac and phenylephrine) FDA Approval History

January 21

Dalvance (dalbavancin)

New Dosage Regimen: January 21, 2016

Dalvance (dalbavancin) FDA Approval History

New Drug Approvals Archive

Hide