New Drug Approvals

New Drug Approvals
The following drugs have recently been approved by the FDA.
Zyprexa Relprevv (olanzapine) for Extended Release Injectable Suspension
Date of Approval: December 11, 2009
Treatment for: Schizophrenia
Zyprexa Relprevv Drug Information | Press Release

Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) Injection
Date of Approval: December 4, 2009
Treatment for: von Willebrand's Disease
Wilate Drug Information | Press Release

Kalbitor (ecallantide) Injection
Date of Approval: December 1, 2009
Treatment for: Angioedema
Kalbitor Drug Information | Press Release

Zegerid OTC (omeprazole and sodium bicarbonate) Capsules
Date of Approval: December 1, 2009
Treatment for: Heartburn
Zegerid OTC Drug Information | Press Release

New Indications and Dosage Forms
Drugs that have gained FDA approval for the treatment of additional
diseases/conditions or new dosage forms/regimens.
Spiriva HandiHaler (tiotropium bromide) Inhalation Powder
Labeling Revision Approved: December 17, 2009
Now Approved for: Reduction of COPD Exacerbations
Spiriva HandiHaler Drug Information | Press Release

Azilect (rasagiline mesylate) Tablets
Labeling Revision Approved: December 9, 2009
Reduced Medication and Food Restrictions
Azilect Drug Information | Press Release

Fluzone (influenza virus vaccine, inactivated) Suspension for
Intramuscular Injection
New Formulation Approved: December 23, 2009
Now Approved: Fluzone High-Dose
Fluzone Drug Information | Press Release

Seroquel XR (quetiapine) Tablets
New Indication Approved: December 2, 2009
Now Approved for: Add-On Treatment of Major Depressive Disorder
Seroquel XR Drug Information | Press Release

Zyprexa (olanzapine)
Patient Population Altered: December 4, 2009
Now Approved for: Schizophrenia and Bipolar I Disorder in Adolescents
Zyprexa Drug Information | Press Release

First-Time Generic Approvals
First Time Generics are those drug products that have never been
approved before as generic drug products and are new generic products
to the marketplace.
Ketorolac Tromethamine Ophthalmic Solution
0.5%
Approved: November 5, 2009 Alcon Inc.; Akorn Inc.; Sun Pharma Global, Inc.
Generic for: Acular Ophthalmic Solution

Ketorolac Tromethamine Ophthalmic Solution
0.4%
Approved: November 5, 2009 Apotex Inc.; Alcon Inc.; Akorn Inc.
Generic for: Acular LS Ophthalmic Solution

Norethindrone Acetate and Ethinyl Estradiol Tablets
USP, 1 mg/0.005 mg
Approved: November 6, 2009 Barr Laboratories, Inc.
Generic for: Femhrt Tablets 1 mg/0.005 mg

Lansoprazole Delayed-Release Capsules
USP, 15 mg and 30 mg
Approved: November 10, 2009 Teva Pharmaceuticals USA; Matrix
Laboratories Limited
Generic for: Prevacid Delayed-Release Capsules

Perindopril Erbumine Tablets
2 mg, 4 mg and 8 mg
Approved: November 10, 2009 Aurobindo Pharma Limited; Roxane
Laboratories, Inc.; IVAX Pharmaceuticals, Inc.
Generic for: Aceon Tablets

Tramadol Hydrochloride Extended-Release Tablets
100 mg and 200 mg
Approved: November 13, 2009 Par Pharmaceutical, Inc.
Generic for: Ultram ER Tablets, 100 mg and 200 mg

Nicardipine Hydrochloride Injection
2.5 mg/mL; packaged in 25 mg/10 mL Single-Dise Vials
Approved: November 17, 2009 Generamedix, Inc.; Pharmaforce, Inc.;
Navinta, LLC; Sun Pharma Global, Inc.; Wockhardt Limited
Generic for: Cardene I.V. Injection

Nizatidine Oral Solution
15 mg/mL
Approved: November 18, 2009 Amneal Pharmaceuticals
Generic for: Axid Oral Solution

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