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New Drug Approvals Archive

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December 2003

December 1

Zorbtive (somatropin) for Injection

Date of Approval: December 1, 2003
Company: Serono, Inc.
Treatment for: Short Bowel Syndrome

Zorbtive [somatropin (rDNA origin) for injection] is recombinant human growth hormone indicated for the treatment of Short Bowel Syndrome in patients receiving specialized nutritional support.

December 11

Ertaczo (sertaconazole topical) Cream

Date of Approval: December 11, 2003
Company: Mylan Pharmaceuticals Inc.
Treatment for: Tinea Pedis

Ertaczo (sertaconazole) is an imidazole derivative antifungal indicated for the treatment of tinea pedis.

December 12

Restylane (dermal filler) Injectable Gel

Date of Approval: December 12, 2003
Company: Medicis
Treatment for: Facial Wrinkles

Restylane is a dermal filler made of a biodegradable non-animal stabilized hyaluronic acid used for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, the lines between the nose and mouth.

December 19

Oraqix (lidocaine and prilocaine ) Periodontal Gel

Date of Approval: December 19, 2003
Company: Dentsply Pharmaceutical
Treatment for: Periodontal Anesthesia

Oraqix is a non-injectable anesthetic for periodontal applications. The anesthetic is delivered to the treatment site without the use of a needle and anesthetizes the site within 30 seconds for a period of approximately 20 minutes.

December 24

Symbyax (fluoxetine and olanzapine) Capsules

Date of Approval: December 24, 2003
Company: Eli Lilly
Treatment for: Bipolar Disorder, Depression

Symbyax (fluoxetine/olanzapine) is a selective serotonin reuptake inhibitor and atypical antipsycotic combination indicated for the acute treatment of depressive episodes associated with bipolar I disorder and treatment resistant depression.

March 23

Symbyax (fluoxetine and olanzapine)

New Indication Approved: March 19, 2009

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