New Drug Approvals Archive
Patient Population Altered: April 28, 2006
Oracea (doxycycline) Capsules
Date of Approval: May 26, 2006
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.
Seasonique (levonorgestrel and ethinyl estradiol) Extended-Cycle Oral Contraceptive Tablets
Date of Approval: May 25, 2006
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.
Omnitrope (somatropin (rDNA origin))
New Formulation Approved: August 25, 2008
Azilect (rasagiline mesylate)
Labeling Revision Approved: December 9, 2009
New Dosage Regimen: March 11, 2010
Zostavax (zoster vaccine live)
Patient Population Altered: March 24, 2011