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New Drug Approvals Archive - December 2010

December 2010

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.

Read more: Safyral (drospirenone, ethinyl estradiol and levomefolate calcium) FDA Approval History

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant)

New Indication Approved: December 22, 2010

Read more: Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) FDA Approval History

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.

Read more: Amturnide (aliskiren, amlodipine and hydrochlorothiazide) FDA Approval History

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.

Read more: Fortesta (testosterone) FDA Approval History

New Drug Approvals Archive