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New Drug Approvals Archive - June 2014

See also: New Indications and Dosage Forms for June 2014

June 2014

Vogelxo (testosterone) Transdermal Gel

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

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

Eloctate (antihemophilic factor (recombinant)) for Injection

Date of Approval: June 6, 2014
Company: Biogen Idec, Inc.
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.

Jublia (efinaconazole) Topical Solution

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

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

Bunavail (buprenorphine and naloxone) Buccal Film

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

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

Sivextro (tedizolid phosphate) Tablets and Injection

Date of Approval: June 20, 2014
Company: Cubist Pharmaceuticals, Inc.
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).

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

Date of Approval: June 27, 2014
Company: MannKind Corporation
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.

Vazculep (phenylephrine hydrochloride) Injection

Date of Approval: June 27, 2014
Company: Flamel Technologies
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.

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