New Drug Approvals Archive - July 2014
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See also: New Indications and Dosage Forms for July 2014
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).
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.
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.
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).
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.
Targiniq ER (naloxone and oxycodone) Extended-Release Tablets
Date of Approval: July 23, 2014
Company: Purdue Pharma L.P.
Treatment for: Pain
Marketing Status: Discontinued
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.
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.
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.
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.
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).
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