New Drug Approvals Archive - December 2009

Intelence (etravirine)

Labeling Revision Approved: November 24, 2009

• U.S. Food And Drug Administration (FDA) Grants Traditional Approval for Intelence (etravirine)
• Intelence (etravirine) FDA Approval History

Zegerid OTC (omeprazole and sodium bicarbonate) Capsules

Date of Approval: December 1, 2009
Company: Merck & Co. and Santarus Inc.
Treatment for: Heartburn

Zegerid OTC (omeprazole and sodium bicarbonate) is an over-the-counter version of the prescription heartburn drug Zegerid.

• FDA Approves OTC Version Of Heartburn Drug Zegerid
• Zegerid OTC (omeprazole and sodium bicarbonate) FDA Approval History

Vagifem (estradiol)

New Dosage Regimen: November 25, 2009

• FDA Approves 10 mcg Dose of Vagifem for the Treatment of Atrophic Vaginitis Due to Menopause

Kalbitor (ecallantide) Injection - formerly DX-88

Date of Approval: December 1, 2009
Company: Dyax Corp.
Treatment for: Angioedema

Kalbitor (ecallantide) is plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.

• Dyax Announces FDA Approval of Kalbitor (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older
• Kalbitor (ecallantide) FDA Approval History

Seroquel XR (quetiapine)

New Indication Approved: December 2, 2009

• FDA Approves Seroquel XR For Add-On Treatment of Major Depressive Disorder
• Seroquel XR (quetiapine) FDA Approval History

Zyprexa (olanzapine)

Patient Population Altered: December 4, 2009

• FDA Approves Lilly's Zyprexa for Two Adolescent Indications

Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) Injection

Date of Approval: December 4, 2009
Company: Octapharma USA
Treatment for: von Willebrand's Disease

Wilate is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD).

• Octapharma USA Announces FDA Approval of Wilate - the First Replacement Therapy Developed Specifically for von Willebrand Disease
• Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) FDA Approval History

Zyprexa Relprevv (olanzapine) for Extended Release Injectable Suspension

Date of Approval: December 11, 2009
Company: Lilly
Treatment for: Schizophrenia

Zyprexa Relprevv (olanzapine) is a long-acting atypical antipsychotic for intramuscular injection indicated for the treatment of schizophrenia.

• FDA Approves Lilly's Zyprexa Relprevv for Treatment of Schizophrenia in Adults
• Zyprexa Relprevv (olanzapine) FDA Approval History

Azilect (rasagiline mesylate)

Labeling Revision Approved: December 9, 2009

• FDA Approves Newly Revised Prescribing Information for Azilect Reducing Medication and Food Restrictions
• Azilect (rasagiline mesylate) FDA Approval History

Spiriva (tiotropium bromide)

Labeling Revision Approved: December 17, 2009

• FDA Approves Spiriva HandiHaler for the Reduction of COPD Exacerbations
• Spiriva (tiotropium bromide) FDA Approval History

Fluzone (influenza virus vaccine, inactivated)

New Formulation Approved: December 23, 2009

• FDA Approves a High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older

Kalbitor (ecallantide)

New Dosage Form Approved: April 3, 2014

• FDA Approves Expanded Use of Kalbitor for the Treatment of HAE to Patients 12 Years of Age and Older
• Kalbitor (ecallantide) FDA Approval History