New Drug Approvals Archive

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May 2010

May 3

Creon (pancrelipase)

Labeling Revision Approved: April 30, 2010

Creon (pancrelipase) FDA Approval History

May 6

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.

Natazia (dienogest and estradiol valerate) FDA Approval History

May 14

Sprix (ketorolac tromethamine) Nasal Spray - formerly ROX-888

Date of Approval: May 14, 2010
Company: Roxro Pharma, Inc.
Treatment for: Pain

Sprix (ketorolac tromethamine) is an intranasal analgesic for the management of acute moderate to severe pain.

Sprix (ketorolac tromethamine) FDA Approval History

May 18

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.

Zymaxid (gatifloxacin) FDA Approval History

May 24

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.

Lumizyme (alglucosidase alfa) FDA Approval History

May 28

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) FDA Approval History

March 15

Natazia (dienogest and estradiol valerate)

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

Natazia (dienogest and estradiol valerate) FDA Approval History

August 1

Lumizyme (alglucosidase alfa)

Patient Population Altered: August 1, 2014

Lumizyme (alglucosidase alfa) FDA Approval History

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