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

Byetta (exenatide) FDA Approval History

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

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

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

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

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

Revatio (sildenafil citrate) FDA Approval History

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

Agriflu (influenza virus vaccine, inactivated) FDA Approval History

Cymbalta (duloxetine)

New Indication Approved: November 30, 2009

• FDA Approves Cymbalta for Maintenance Treatment of Generalized Anxiety Disorder

Cymbalta (duloxetine) FDA Approval History

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

Istodax (romidepsin) FDA Approval History