New Drug Approvals Archive

New Drug Approvals: May 2006

May 1
Nexium (esomeprazole)

Patient Population Altered: April 28, 2006

Nexium Approved for Children 12 to 17 For Short-Term Treatment of GERD
 
May 26
Oracea (doxycycline) Capsules

Date of Approval: May 26, 2006

Company: CollaGenex Pharmaceuticals, Inc.

Treatment for Acne Rosacea

Oracea is a once-a-day capsule formulation of doxycycline, consisting a combination of immediate and delayed release beads. Oracea is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients.

Oracea CollaGenex Pharmaceuticals, Inc. - Treatment for Rosacea
 
May 27
Seasonique (levonorgestrel/ethinyl estradiol) Extended-Cycle Oral Contraceptive Tablets

Date of Approval: May 25, 2006

Company: Duramed Pharmaceuticals, Inc.

Treatment for Contraception

Seasonique is an extended-cycle oral contraceptive regimen designed to reduce the number of withdrawal bleeding periods from monthly to four per year. Seasonique is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of birth control.

FDA Approves Duramed's Seasonique Extended-Cycle Oral Contraceptive
 

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