New Drug Approvals Archive
New Drug Approvals: November 2009
| November 2 | Byetta (exenatide)
New Indication Approved: November 2, 2009 Byetta Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes |
| November 4 | 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. FDA Approves Pennsaid Topical Solution |
| November 5 | 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. FDA Approves Gloucester Pharmaceuticals' Istodax for Patients with Cutaneous T-cell Lymphoma |
| November 6 | Reyataz (atazanavir sulfate)
Labeling Revision Approved: November 5, 2009 FDA Approves Labeling Update for Reyataz (atazanavir sulfate) Capsules to Include 96-Week Data for Previously Untreated HIV-1 Infected Adult Patients |
| November 13 |
Patient Population Altered: November 10, 2009 Treatment for: Prevention of H1N1 Influenza FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children |
| November 13 | 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. Xanodyne Announces FDA Approval of Lysteda (Tranexamic Acid) for Treatment of Women with Heavy Menstrual Bleeding |
| November 16 | 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. NeurogesX Receives FDA Approval of Qutenza (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN) |
| November 20 | Revatio (sildenafil citrate)
New Dosage Form Approved: November 18, 2009 FDA Approves Intravenous Formulation Of Pfizer's Revatio (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension |
New Drug Approvals Archive
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