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New Drug Approvals Archive - December 2009

See also: New Indications and Dosage Forms for December 2009

December 2009

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.

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.

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

Date of Approval: December 4, 2009
Company: Octapharma USA
Treatment for: von Willebrand 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).

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.

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