New Drug Approvals Archive - May 2010

Creon (pancrelipase)

Labeling Revision Approved: April 30, 2010

• Abbott Receives FDA Approval for Creon to Include Dosing Information for Patients With Chronic Pancreatitis and Pancreatectomy

Creon (pancrelipase) FDA Approval History

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.

• FDA Approves Natazia - New Combination Product Oral Contraceptive

Natazia (dienogest and estradiol valerate) FDA Approval History

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.

• Roxro Announces FDA Approval of Sprix

Sprix (ketorolac tromethamine) FDA Approval History

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.

• Allergan Receives FDA Approval for Zymaxid Ophthalmic Solution

Zymaxid (gatifloxacin) FDA Approval History

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.

• FDA Approves Lumizyme for Late-Onset Pompe Disease

Lumizyme (alglucosidase alfa) FDA Approval History

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.

• Cysview (Hexaminolevulinate HCl) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer

Cysview (hexaminolevulinate) FDA Approval History

Natazia (dienogest and estradiol valerate)

New Indication Approved: March 14, 2012
Treatment for: Contraception, Heavy Menstrual Bleeding

• U.S. FDA Approves First and Only Oral Contraceptive Demonstrated to Treat Heavy Menstrual Bleeding (HMB)

Natazia (dienogest and estradiol valerate) FDA Approval History

Lumizyme (alglucosidase alfa)

Patient Population Altered: August 1, 2014

• FDA Expands Approval of Lumizyme to treat Pompe Disease Patients of All Ages

Lumizyme (alglucosidase alfa) FDA Approval History