New Drug Approvals Archive - May 2006

Nexium (esomeprazole)

Patient Population Altered: April 28, 2006

• Nexium Approved for Children 12 to 17 For Short-Term Treatment of GERD

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
• Oracea (doxycycline) FDA Approval History

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.

• FDA Approves Duramed's Seasonique Extended-Cycle Oral Contraceptive
• Seasonique (levonorgestrel and ethinyl estradiol) FDA Approval History

Omnitrope (somatropin (rDNA origin))

New Formulation Approved: August 25, 2008

• Sandoz Receives FDA Approval for Omnitrope Pen 10 With Liquid Cartridge
• Omnitrope (somatropin (rDNA origin)) FDA Approval History

Azilect (rasagiline mesylate)

Labeling Revision Approved: December 9, 2009

• FDA Approves Newly Revised Prescribing Information for Azilect Reducing Medication and Food Restrictions
• Azilect (rasagiline mesylate) FDA Approval History

Dacogen (decitabine)

New Dosage Regimen: March 11, 2010

• FDA Approves Five-Day Dosing Regimen for Dacogen (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS)
• Dacogen (decitabine) FDA Approval History

Zostavax (zoster vaccine live)

Patient Population Altered: March 24, 2011

• FDA Expands Indication for Zostavax, Merck's Shingles Vaccine, to Include Adults Ages 50 to 59
• Zostavax (zoster vaccine live) FDA Approval History