New Drug Approvals Archive

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May 2006

May 1

Nexium (esomeprazole)

Patient Population Altered: April 28, 2006

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 (doxycycline) FDA Approval History

May 25

Seasonique (levonorgestrel and ethinyl estradiol) Extended-Cycle Oral Contraceptive Tablets

Date of Approval: May 25, 2006
Company: Duramed Pharmaceuticals, Inc.
Treatment for: Contraception

Seasonique (levonorgestrel/ethinyl estradiol) 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.

Seasonique (levonorgestrel and ethinyl estradiol) FDA Approval History

September 3

Omnitrope (somatropin (rDNA origin))

New Formulation Approved: August 25, 2008

Omnitrope (somatropin (rDNA origin)) FDA Approval History

December 14

Azilect (rasagiline mesylate)

Labeling Revision Approved: December 9, 2009

Azilect (rasagiline mesylate) FDA Approval History

March 12

Dacogen (decitabine)

New Dosage Regimen: March 11, 2010

Dacogen (decitabine) FDA Approval History

March 25

Zostavax (zoster vaccine live)

Patient Population Altered: March 24, 2011

Zostavax (zoster vaccine live) FDA Approval History

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