New Drug Approvals Archive - July 2014

Beleodaq (belinostat) Injection

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

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

• FDA Approves Beleodaq (belinostat) for Peripheral T-Cell Lymphoma
• Beleodaq (belinostat) FDA Approval History

Kerydin (tavaborole) Topical Solution

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

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

• FDA Approves Kerydin (tavaborole) Topical Solution for Onychomycosis of the Toenails
• Kerydin (tavaborole) FDA Approval History

Rasuvo (methotrexate) Injection - formerly MPI-2505

Date of Approval: July 11, 2014
Company: Medac Pharma, Inc.
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.

• FDA Approves Rasuvo (methotrexate) Injection
• Rasuvo (methotrexate) FDA Approval History

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

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

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

• FDA Approves Ruconest for Hereditary Angioedema
• Ruconest (C1 esterase inhibitor (recombinant)) FDA Approval History

Zydelig (idelalisib) Tablets

Date of Approval: July 23, 2014
Company: Gilead Sciences, Inc.
Treatment for: non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma

Zydelig (idelalisib) is a phosphoinositide 3-kinase (PI3K) delta inhibitor for the treatment of chronic lymphocytic leukemia, relapsed follicular B-cell non-Hodgkin lymphoma, and relapsed small lymphocytic lymphoma.

• FDA Approves Zydelig (idelalisib) for CLL and Lymphoma
• Zydelig (idelalisib) FDA Approval History

Targiniq ER (naloxone and oxycodone) Extended-Release Tablets

Date of Approval: July 23, 2014
Company: Purdue Pharma L.P.
Treatment for: Pain

Targiniq ER (naloxone and oxycodone) is an opioid antagonist and opioid analgesic combination in a long-acting abuse-deterrent formulation for the management of chronic severe pain.

• FDA Approves Targiniq ER Extended-Release Oxycodone with Abuse-Deterrent Properties
• Targiniq ER (naloxone and oxycodone) FDA Approval History

Ryanodex (dantrolene) Injectable Suspension

Date of Approval: July 22, 2014
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Malignant Hyperthermia

Ryanodex (dantrolene) is a skeletal muscle relaxant in a concentrated formulation for the treatment of malignant hyperthermia.

• FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia
• Ryanodex (dantrolene) FDA Approval History

Flonase Allergy Relief (fluticasone propionate) Nasal Spray

Date of Approval: July 23, 2014
Company: GlaxoSmithKline plc
Treatment for: Allergic Rhinitis

Flonase Allergy Relief (fluticasone propionate) is a once-a-day, over-the-counter corticosteroid nasal spray indicated for the relief hay fever symptoms.

• FDA Approves Flonase Allergy Relief for Sale Over-the-Counter in the United States
• Flonase Allergy Relief (fluticasone propionate) FDA Approval History

Acticlate (doxycycline hyclate) Tablets

Date of Approval: July 25, 2014
Company: Aqua Pharmaceuticals, LLC
Treatment for: Bacterial Infection, Acne

Acticlate (doxycycline hyclate) is a tetracycline-class antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne.

• Aqua Pharmaceuticals Announces FDA Approval of Acticlate (doxycycline hyclate USP) Tablets
• Acticlate (doxycycline hyclate) FDA Approval History

Imbruvica (ibrutinib)

New Indication Approved: July 28, 2014
Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma; Chronic Graft Versus Host Disease

• FDA Expands Approved Use of Imbruvica (ibrutinib) for Chronic Lymphocytic Leukemia
• Imbruvica (ibrutinib) FDA Approval History

Eylea (aflibercept)

New Indication Approved: July 29, 2014
Treatment for: Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetic Macular Edema

• Eylea (aflibercept) Injection Receives FDA Approval for the Treatment of Diabetic Macular Edema
• Eylea (aflibercept) FDA Approval History

Striverdi Respimat (olodaterol) Inhalation Spray

Date of Approval: July 31, 2014
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Treatment for: Chronic Obstructive Pulmonary Disease

Striverdi Respimat (olodaterol) is a once-daily, long-acting beta-agonist (LABA) for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

• FDA Approves Striverdi Respimat to Treat Chronic Obstructive Pulmonary Disease
• Striverdi Respimat (olodaterol) FDA Approval History