New Drug Approvals Archive
Labeling Revision Approved: April 30, 2010
Natazia (dienogest and estradiol valerate) - formerly Qlaira
Date of Approval: May 6, 2010
Natazia (dienogest and estradiol valerate) is a combination oral contraceptive indicated for use by women to prevent pregnancy and to treat heavy menstrual bleeding.
Sprix (ketorolac tromethamine) Nasal Spray - formerly ROX-888
Date of Approval: May 14, 2010
Sprix (ketorolac tromethamine) is an intranasal analgesic for the management of acute moderate to severe pain.
Zymaxid (gatifloxacin) Ophthalmic Solution
Date of Approval: May 18, 2010
Zymaxid (gatifloxacin ophthalmic) is a fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Lumizyme (alglucosidase alfa)
Date of Approval: May 24, 2010
Lumizyme (alglucosidase alfa) is a lysosomal glycogen-specific enzyme indicated for patients 8 years and older with late (non-infantile) onset Pompe disease.
Cysview (hexaminolevulinate) for Intravesical Solution - formerly Hexvix
Date of Approval: May 28, 2010
Cysview (hexaminolevulinate HCl) is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder.
Natazia (dienogest and estradiol valerate)
New Indication Approved: March 14, 2012