New Drug Approvals Archive - November 2009
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See also: New Indications and Dosage Forms for November 2009
November 2009
Pennsaid (diclofenac sodium) Topical Solution
Date of Approval: November 4, 2009
Company: Nuvo Research Inc.
Treatment for: Osteoarthritis
Pennsaid is a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of signs and symptoms of osteoarthritis of the knee.
Istodax (romidepsin) for Injection
Date of Approval: November 5, 2009
Company: Gloucester Pharmaceuticals
Treatment for: Cutaneous T-cell Lymphoma
Istodax (romidepsin) a histone deacetylase (HDAC) inhibitor indicated the treatment of cutaneous T-cell lymphoma and peripheral T-cell lymphoma.
Lysteda (tranexamic acid) Tablets - formerly XP12B
Date of Approval: November 13, 2009
Company: Xanodyne Pharmaceuticals, Inc.
Treatment for: Menorrhagia
Lysteda (tranexamic acid) is an antifibrinolytic agent for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms.
Qutenza (capsaicin) Transdermal Patch - formerly NGX-4010
Date of Approval: November 16, 2009
Company: NeurogesX, Inc.
Treatment for: Postherpetic Neuralgia
Qutenza, formerly NGX-4010, is a capsaicin transdermal patch for the management of pain due to postherpetic neuralgia.
Agriflu (influenza virus vaccine, inactivated) Injection
Date of Approval: November 27, 2009
Company: Novartis Vaccines and Diagnostics, Inc.
Treatment for: Influenza Prophylaxis
Agriflu (influenza virus vaccine, inactivated) is a vaccine indicated for the active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
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