New Drug Approvals Archive

Cubicin (daptomycin )

New Dosage Regimen: November 30, 2010

• Cubist Pharmaceuticals Receives FDA Approval for 2-Minute IV Injection of Cubicin

Prezista (darunavir)

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

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.

• FDA Approves Safyral - Oral Contraceptive That Also Raises Folate Levels

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

• FDA: Gardasil Approved to Prevent Anal Cancer

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.

• Novartis Gains FDA Approval for Amturnide, a Triple-Combination Pill to Treat High Blood Pressure in Patients Uncontrolled on Two Medications

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.

• Endo Pharmaceuticals Receives FDA Approval for Fortesta (Testosterone) Gel as a Class III Product for Topical Use for Men With Low Testosterone

Fortesta (testosterone) FDA Approval History