New Drug Approvals Archive - November 2009

Byetta (exenatide)

New Indication Approved: November 2, 2009

Byetta Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes

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

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

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

Influenza A (H1N1) 2009 Monovalent Vaccine (H1N1 influenza virus vaccine)

Patient Population Altered: November 10, 2009
Treatment for: Prevention of H1N1 Influenza

FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children

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

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)

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

Abilify (aripiprazole)

New Indication Approved: November 19, 2009

U.S. Food and Drug Administration Approves Abilify (aripiprazole) for the Treatment of Irritability Associated with Autistic Disorder in Pediatric Patients (Ages 6 to 17 Years)

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

Cymbalta (duloxetine)

New Indication Approved: November 30, 2009

FDA Approves Cymbalta for Maintenance Treatment of Generalized Anxiety Disorder

Istodax (romidepsin)

New Indication Approved: June 16, 2011

FDA Grants Accelerated Approval of Istodax As Treatment for Patients with Peripheral T-Cell Lymphoma Who Have Received at Least One Prior Therapy