New Drug Approvals Archive

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December 2010

December 2

Cubicin (daptomycin )

New Dosage Regimen: November 30, 2010

December 14

Prezista (darunavir)

New Dosage Regimen: December 13, 2010

Prezista (darunavir) FDA Approval History

December 16

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.

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

December 22

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

New Indication Approved: December 22, 2010

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

December 21

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.

Amturnide (aliskiren, amlodipine and hydrochlorothiazide) FDA Approval History

December 29

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.

Fortesta (testosterone) FDA Approval History

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