New Drug Approvals

New Drug Approvals
The following drugs have recently been approved by the FDA.
Acuvail (ketorolac tromethamine) Ophthalmic Solution
Date of Approval: July 22, 2009
Treatment for: Postoperative Ocular Inflammation
Acuvail Drug Information | Press Release

Onsolis (fentanyl) Buccal Soluble Film
Date of Approval: July 16, 2009
Treatment for: Pain
Onsolis Drug Information | Press Release

Sumavel DosePro (sumatriptan) Injection
Date of Approval: July 15, 2009
Treatment for: Migraine, Cluster Headache
Sumavel DosePro Drug Information | Press Release

Plan B One-Step (levonorgestrel) Tablet
Date of Approval: July 10, 2009
Treatment for: Emergency Contraception
Plan B One-Step Drug Information | Press Release

Effient (prasugrel) Tablets
Date of Approval: July 10, 2009
Treatment for: Acute Coronary Syndrome
Effient Drug Information | Press Release

Multaq (dronedarone) Tablets
Date of Approval: July 1, 2009
Treatment for: Atrial Fibrillation, Atrial Flutter
Multaq Drug Information | Press Release

Feraheme (ferumoxytol) Intravenous Injection
Date of Approval: June 30, 2009
Treatment for: Anemia Associated with Chronic Renal Failure
Feraheme 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.
NovoLog (insulin aspart) Injection
Expiration Date Change Approved: July 14, 2009
Now Approved: Six Day Storage in Insulin Pumps
NovoLog Drug Information | Press Release

Forteo (teriparatide (rDNA origin)) Injection
New Indication Approved: July 22, 2009
Now Approved for: Glucocorticoid-Induced Osteoporosis
Forteo Drug Information | Press Release

Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets
New Indication Approved: July 16, 2009
Now Approved for: Initial Therapy of Hypertension
Tekturna HCT 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.
Norgestimate and Ethinyl Estradiol Tablets
USP, 0.180 mg/0.025 mg; 0.215 mg/0.025 mg and 0.250 mg/0.025 mg (28-Day Regimen)
Approved: June 29, 2009 Barr Laboratories, Inc.
Generic for: Ortho Tri Cyclen Lo

Oxcarbazepine Oral Suspension
300 mg/5 mL
Approved: June 26, 2009 Ranbaxy Laboratories Limited
Generic for: Trileptal Oral Suspension

Levonorgestrel Tablets
(Rx) 0.75 mg
Approved: June 24, 2009 Watson Laboratories, Inc.
Generic for: Plan B (levonorgestrel) Tablets, 0.75 mg

Melphalan Hydrochloride for Injection
50 mg (base)/vial
Approved: June 9, 2009 Synerx Pharma, LLC
Generic for: Alkeran for Injection

Omeprazole Magnesium Delayed-Release Capsules
(OTC) 20 mg (base)
Approved: June 6, 2009 Dr. Reddy's Laboratories Limited
Generic for: Prilosec OTC Delayed-Release Capsules

Triamcinolone Acetonide Injectable Suspension
USP, 40 mg/mL; packaged in 40 mg/1 mL vials and 200 mg/5 mL and 400
mg/10 mL multiple-dose vials
Approved: June 1, 2009 Sandoz Canada Inc.
Generic for: Kenalog-40 Injectable Suspension