New Drug Approvals Archive

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December 2009

December 2

Intelence (etravirine)

Labeling Revision Approved: November 24, 2009

Intelence (etravirine) FDA Approval History

December 1

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.

Zegerid OTC (omeprazole and sodium bicarbonate) FDA Approval History

December 2

Vagifem (estradiol)

New Dosage Regimen: November 25, 2009

December 1

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.

Kalbitor (ecallantide) FDA Approval History

December 4

Seroquel XR (quetiapine)

New Indication Approved: December 2, 2009

Seroquel XR (quetiapine) FDA Approval History

December 7

Zyprexa (olanzapine)

Patient Population Altered: December 4, 2009

December 4

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).

Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) FDA Approval History

December 11

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.

Zyprexa Relprevv (olanzapine) FDA Approval History

December 14

Azilect (rasagiline mesylate)

Labeling Revision Approved: December 9, 2009

Azilect (rasagiline mesylate) FDA Approval History

December 18

Spiriva (tiotropium bromide)

Labeling Revision Approved: December 17, 2009

Spiriva (tiotropium bromide) FDA Approval History

December 23

Fluzone (influenza virus vaccine, inactivated)

New Formulation Approved: December 23, 2009

April 7

Kalbitor (ecallantide)

New Dosage Form Approved: April 3, 2014

Kalbitor (ecallantide) FDA Approval History

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