New Drug Approvals Archive

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August 2010

August 5

Taxotere (docetaxel)

New Dosage Form Approved: August 5, 2010

August 5

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.

Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) FDA Approval History

August 10

Valcyte (valganciclovir)

New Dosage Regimen: August 5, 2010

August 13

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.

ella (ulipristal acetate) FDA Approval History

August 26

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.

Tekamlo (aliskiren and amlodipine) FDA Approval History

August 31

Suboxone (buprenorphine and naloxone)

New Formulation Approved: August 31, 2010

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