New Drug Approvals Archive - December 2010
Cubicin (daptomycin )
New Dosage Regimen: November 30, 2010
New Dosage Regimen: December 13, 2010
- FDA Approves Prezista/ritonavir Once-Daily Dosing for HIV-1 Treatment-Experienced Adults With No Darunavir Resistance-Associated Mutations
Read more: Prezista (darunavir) FDA Approval History
Safyral (drospirenone, ethinyl estradiol and levomefolate calcium) Tablets
Date of Approval: December 16, 2010
Company: Bayer HealthCare Pharmaceuticals, Inc.
Treatment for: Contraception
Safyral (drospirenone, ethinyl estradiol and levomefolate calcium) is an estrogen/progestin combined oral contraceptive containing a folate, indicated for use by women to prevent pregnancy, and to raise folate levels in women who choose to use an oral contraceptive for contraception.
Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant)
New Indication Approved: December 22, 2010
Amturnide (aliskiren, amlodipine and hydrochlorothiazide) Tablets
Date of Approval: December 21, 2010
Company: Novartis Pharmaceuticals Corporation
Treatment for: Hypertension
Amturnide (aliskiren, amlodipine and hydrochlorothiazide) is a direct renin inhibitor, calcium channel blocker and diuretic combination for the treatment of high blood pressure.
- Novartis Gains FDA Approval for Amturnide, a Triple-Combination Pill to Treat High Blood Pressure in Patients Uncontrolled on Two Medications
Fortesta (testosterone) Gel
Date of Approval: December 29, 2010
Company: Endo Pharmaceuticals
Treatment for: Hypogonadism -- Male
Fortesta (testosterone) Gel is a topical androgen indicated for replacement therapy in male hypogonadism.
- Endo Pharmaceuticals Receives FDA Approval for Fortesta (Testosterone) Gel as a Class III Product for Topical Use for Men With Low Testosterone
Read more: Fortesta (testosterone) FDA Approval History