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New Drug Approvals Archive - May 2010

May 2010

Natazia (dienogest and estradiol valerate) - formerly Qlaira

Date of Approval: May 6, 2010
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Contraception, Heavy Menstrual Bleeding

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
Company: Egalet Corporation
Treatment for: Pain

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
Company: Allergan, Inc.
Treatment for: Bacterial Conjunctivitis

Zymaxid (gatifloxacin ophthalmic) is a fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.

Lumizyme (alglucosidase alfa)

Date of Approval: May 24, 2010
Company: Genzyme Corporation
Treatment for: Pompe disease

Lumizyme (alglucosidase alfa) is a lysosomal glycogen-specific enzyme indicated for patients with Pompe disease.

Cysview (hexaminolevulinate) for Intravesical Solution - formerly Hexvix

Date of Approval: May 28, 2010
Company: Photocure ASA
Treatment for: Diagnostic

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
Treatment for: Contraception, Heavy Menstrual Bleeding

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