New Drug Approvals Archive - November 2009

Pennsaid (diclofenac sodium) Topical Solution

Date of Approval: November 4, 2009
Company: Nuvo Research Inc.
Treatment for: Osteoarthritis

Marketing Status: Discontinued

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
• Pennsaid (diclofenac sodium) FDA Approval History

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.

• FDA Approves Gloucester Pharmaceuticals' Istodax for Patients with Cutaneous T-cell Lymphoma
• Istodax (romidepsin) FDA Approval History

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
• Lysteda (tranexamic acid) FDA Approval History

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)
• Qutenza (capsaicin) FDA Approval History

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.

• FDA Approves Agriflu Seasonal Influenza Vaccine
• Agriflu (influenza virus vaccine, inactivated) FDA Approval History