New Drug Approvals Archive - November 2009
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
Date of Approval: November 16, 2009
Company: Averitas Pharma, Inc.
Treatment for: Neuropathic Pain, Postherpetic Neuralgia, Diabetic Neuropathy
Qutenza (capsaicin) is a TRPV1 channel agonist indicated for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.
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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