New Drug Approvals Archive - 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.

• Upsher-Smith Receives Final NDA Approval For Vogelxo (testosterone) Gel

Vogelxo (testosterone) FDA Approval History

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.

• FDA Approves Eloctate - first Antihemophilic Factor, Fc Fusion Protein for Patients with Hemophilia A

Eloctate (antihemophilic factor (recombinant)) FDA Approval History

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.

• Valeant Pharmaceuticals Announces FDA Approval Of Jublia for the Treatment of Onychomycosis

Jublia (efinaconazole) FDA Approval History

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.

• FDA Approves Bunavail Buccal Film for the Maintenance Treatment of Opioid Dependence

Bunavail (buprenorphine and naloxone) FDA Approval History

Lymphoseek (technetium Tc 99m tilmanocept)

New Indication Approved: June 13, 2014

• FDA Approves Lymphoseek to Help Determine the Extent of Head and Neck Cancer in the Body

Lymphoseek (technetium Tc 99m tilmanocept) FDA Approval History

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).

• FDA Approves Sivextro (tedizolid phosphate) to Treat Skin Infections

Sivextro (tedizolid phosphate) FDA Approval History

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.

• FDA Approves Afrezza to Treat Diabetes

Afrezza (insulin human [rDNA origin]) FDA Approval History

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.

• Flamel Technologies Announces FDA Approval of Vazculep

Vazculep (phenylephrine hydrochloride) FDA Approval History