New Drug Approvals

New Drug Approvals
The following drugs have recently been approved by the FDA.
Dulera (mometasone furoate and formoterol fumarate) Inhaler
Date of Approval: June 22, 2010
Treatment for: Asthma
Dulera Drug Information | Press Release
Jevtana (cabazitaxel) Injection
Date of Approval: June 17, 2010
Treatment for: Prostate Cancer
Jevtana Drug Information | Press Release
Jalyn (dutasteride and tamsulosin) Capsules
Date of Approval: June 14, 2010
Treatment for: Benign Prostatic Hyperplasia
Jalyn Drug Information | Press Release
Prolia (denosumab) Injection
Date of Approval: June 1, 2010
Treatment for: Osteoporosis
Prolia 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.
Namenda (memantine hydrochloride)
New Dosage Form Approved: June 21, 2010
Now Approved: Namenda XR
Namenda Drug Information | Press Release
Lucentis (ranibizumab) Injection
New Indication Approved: June 23, 2010
Now Approved for: Macular Edema Following Retinal Vein Occlusion
Lucentis Drug Information | Press Release
Tasigna (nilotinib) Capsules
New Indication Approved: June 17, 2010
Now Approved for: Newly Diagnosed Philadelphia Chromosome-Positive
Chronic Myeloid Leukemia Patients
Tasigna 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.
Trandolapril and Verapamil Hydrochloride Extended Release Tablets
2 mg/180 mg, 2 mg/240 mg and 4 mg/240 mg
Approved: May 5 and 26, 2010 - Glenmark Generics Ltd.
Generic for: Tarka
Zidovudine Injection
10 mg/mL
Approved: May 6, 2010 - PharmaForce, Inc.
Generic for: Retrovir Injection
Omeprazole and Sodium Bicarbonate Capsules
20 mg/1.1 g and 40 mg/1.1 g
Approved: May 25, 2010 - Par Pharmaceutical
Generic for: Zegerid
Famotidine for Suspension
40 mg/5 mL
Approved: May 27, 2010 - Navinta LLC
Generic for: Pepcid for Suspension