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