New Drug Approvals Archive

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February 2012

February 2

Janumet (metformin and sitagliptin)

New Formulation Approved: February 2, 2012

Janumet (metformin and sitagliptin) FDA Approval History

February 7

Vyvanse (lisdexamfetamine dimesylate)

New Indication Approved: January 31, 2012

Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

February 7

Sklice (ivermectin) Lotion

Date of Approval: February 7, 2012
Company: Sanofi Pasteur Inc.
Treatment for: Lice

Sklice (ivermectin) Lotion is a pediculicide indicated for the topical treatment of head lice infestations in patients 6 months of age and older.

Sklice (ivermectin) FDA Approval History

February 7

Mitosol (mitomycin) Ophthalmic Solution

Date of Approval: February 7, 2012
Company: Mobius Therapeutics, LLC
Treatment for: Glaucoma Surgery

Mitosol (mitomycin) is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.

Mitosol (mitomycin) FDA Approval History

February 10

Zioptan (tafluprost) Ophthalmic Solution - formerly Saflutan

Date of Approval: February 10, 2012
Company: Merck & Co., Inc.
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension

Zioptan (tafluprost ophthalmic solution) is a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Zioptan (tafluprost) FDA Approval History

February 14

Bio-T-Gel (testosterone) Topical Gel

Date of Approval: February 14, 2012
Company: BioSante Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.
Treatment for: Hypogonadism -- Male

Bio-T-Gel (testosterone) is a once-daily transdermal testosterone gel for the treatment of male hypogonadism or low testosterone levels.

Bio-T-Gel (testosterone) FDA Approval History

February 17

Korlym (mifepristone) Tablets

Date of Approval: February 17, 2012
Company: Corcept Therapeutics
Treatment for: Cushing's Syndrome

Korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance.

Korlym (mifepristone) FDA Approval History

February 29

Angeliq (drospirenone and estradiol)

New Formulation Approved: February 29, 2012

Angeliq (drospirenone and estradiol) FDA Approval History

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