New Drug Approvals Archive - August 2010
New Dosage Form Approved: August 5, 2010
Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) Oral Solution
Date of Approval: August 5, 2010
Company: Braintree Laboratories, Inc.
Treatment for: Bowel Preparation
Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
New Dosage Regimen: August 5, 2010
ella (ulipristal acetate)
Date of Approval: August 13, 2010
Company: HRA Pharma
Treatment for: Postcoital Contraception
ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.
Tekamlo (aliskiren and amlodipine) Tablets
Date of Approval: August 26, 2010
Company: Novartis Pharmaceuticals Corporation
Treatment for: Hypertension
Tekamlo (aliskiren and amlodipine) is a direct renin inhibitor and calcium channel blocker combination indicated for the treatment of high blood pressure.
- Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure
Suboxone (buprenorphine and naloxone)
New Formulation Approved: August 31, 2010