New Drug Approvals Archive - May 2006
Patient Population Altered: April 28, 2006
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.
Read more: 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.
Omnitrope (somatropin (rDNA origin))
New Formulation Approved: August 25, 2008
Azilect (rasagiline mesylate)
Labeling Revision Approved: December 9, 2009
- FDA Approves Newly Revised Prescribing Information for Azilect Reducing Medication and Food Restrictions
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)
Read more: Dacogen (decitabine) FDA Approval History
Zostavax (zoster vaccine live)
Patient Population Altered: March 24, 2011