New Drug Approvals Archive

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February 2006

February 3

RotaTeq (rotavirus vaccine, live, oral, pentavalent)

Date of Approval: February 3, 2006
Company: Merck & Co., Inc.
Treatment for: Rotavirus Gastroenteritis

RotaTeq (rotavirus vaccine, live, oral, pentavalent) is an oral, three-dose vaccine given to infants between the ages of six to 32 weeks for the prevention of rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young children.

RotaTeq (rotavirus vaccine, live, oral, pentavalent) FDA Approval History

February 16

Vusion (miconazole nitrate, zinc oxide and white petrolatum) Ointment - formerly Zimycan

Date of Approval: February 16, 2006
Company: Barrier Therapeutics, Inc.
Treatment for: Cutaneous Candidiasis

Vusion (miconazole nitrate, zinc oxide and white petrolatum) is a steroid-free ointment for the treatment of diaper dermatitis.

Vusion (miconazole nitrate, zinc oxide and white petrolatum) FDA Approval History

February 17

Eraxis (anidulafungin) Injection

Date of Approval: February 17, 2006
Company: Pfizer Inc.
Treatment for: Candidemia

Eraxis (anidulafungin) is an antifungal medicine of the echinocandin class, indicated for the treatment of candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis) and esophageal candidiasis.

Eraxis (anidulafungin) FDA Approval History

February 17

Loestrin 24 Fe (norethindrone acetate/ethinyl estradiol and ferrous fumarate) Tablets

Date of Approval: February 17, 2006
Company: Warner Chilcott
Treatment for: Contraception

Loestrin 24 Fe (norethindrone acetate/ethinyl estradiol and ferrous fumarate) is an oral contraceptive providing 24 days of active hormonal therapy with four days of iron containing placebo pills. Loestrin 24 Fe is indicated for the prevention of pregnancy.

Loestrin 24 Fe (norethindrone acetate/ethinyl estradiol and ferrous fumarate) FDA Approval History

February 27

Emsam (selegiline) Transdermal System

Date of Approval: February 27, 2006
Company: Somerset Pharmaceuticals, Inc.
Treatment for: Depression

Emsam is a transdermal patch containing the monoamine oxidase inhibitor selegiline. Emsam is indicated for the treatment of major depressive disorder (MDD) in adults.

Emsam (selegiline) FDA Approval History

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