New Drug Approvals

The following drugs have recently been approved by the FDA.
Tekamlo (aliskiren and amlodipine) Tablets
Date of Approval: August 26, 2010
Treatment for: Hypertension

Tekamlo Drug Information | Press Release
ella (ulipristal acetate)
Date of Approval: August 13, 2010
Treatment for: Postcoital Contraception
ella Drug Information | Press Release

Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) Oral Solution
Date of Approval: August 5, 2010
Treatment for: Bowel Preparation
Suprep Drug Information | Press Release
Xeomin (incobotulinumtoxinA)
Date of Approval: July 30, 2010
Treatment for: Cervical Dystonia, Blepharospasm

Xeomin Drug Information | Press Release
More new drug approvals
New Indications and Dosage Forms
Drugs that have gained FDA approval for the treatment of additional
diseases/conditions or new dosage forms/regimens.

Valcyte (valganciclovir) Tablets and Oral Solution
New Dosage Regimen: August 5, 2010
Now Approved: Longer Treatment Period
Valcyte Drug Information | Press Release

More new indications and dosage forms

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.

Naratriptan Hydrochloride Tablets
1 mg (base) and 2.5 mg (base)
Approved: July 7, 2010 - Teva Pharmaceuticals USA Inc.; Sandoz Inc.;
Roxane Laboratories, Inc.
Generic for: Amerge

Clindamycin Palmitate Hydrochloride for Oral Solution
75 mg (base)/5 mL
Approved: July 7, 2010 - Paddock Laboratories, Inc.
Generic for: Cleocin Pediatric Flavored Granules For Oral Solution

Desloratadine Orally Disintegrating Tablets
2.5 mg and 5 mg
Approved: July 12, 2010 - Dr.Reddy's Pharmaceutical Company
Generic for: Clarinex Reditabs