New Drug Approvals

New Drug Approvals
The following drugs have recently been approved by the FDA.
Zenpep (pancrealipase) Capsules
Date of Approval: August 27, 2009
Treatment for: Pancreatic Exocrine Dysfunction
Zenpep Drug Information | Press Release

Sabril (vigabatrin) Tablets and Oral Solution
Date of Approval: August 21, 2009
Treatment for: Epilepsy, Seizures
Sabril Drug Information | Press Release

Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate))
Solution for Intramuscular Injection
Date of Approval: August 19, 2009
Treatment for: Haemophilus influenzae Prophylaxis
Hiberix Drug Information | Press Release

Saphris (asenapine) Sublingual Tablets
Date of Approval: August 13, 2009
Treatment for: Schizophrenia, Bipolar Disorder
Saphris Drug Information | Press Release

Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules
Date of Approval: August 13, 2009
Treatment for: Pain
Embeda Drug Information | Press Release

Livalo (pitavastatin) Tablets
Date of Approval: August 3, 2009
Treatment for: High Cholesterol
Livalo Drug Information | Press Release

Lipsovir (acyclovir and hydrocortisone) Topical Cream
Date of Approval: July 31, 2009
Treatment for: Herpes Simplex Labialis
Lipsovir 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.
Invega (paliperidone)
New Dosage Form Approved: July 31, 2009
Now Approved: Invega Sustenna
Invega Drug Information | Press Release

Invega (paliperidone)
New Indication Approved: July 31, 2009
Now Approved for: Schizoaffective Disorder
Invega Drug Information | Press Release

Avastin (bevacizumab) Injection
New Indication Approved: July 31, 2009
Now Approved for: Metastatic Renal Cell Carcinoma
Avastin Drug Information | Press Release

Xyzal (levocetirizine dihydrochloride)
Patient Population Altered: August 21, 2009
Now Approved for: Allergy Symptoms in Children Six Months and Older
Xyzal 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.
Bicalutamide Tablets
50 mg
Approved: July 6, 2009 Teva Pharmaceuticals; Synthon Pharmaceuticals,
Inc.; Kudco; Sandoz; Accord Healthcare Inc.; Zydus Pharmaceuticals;
Sun Pharmaceutical Industries Ltd; Mylan Pharmaceuticals
Generic for: Casodex