New Drug Approvals Archive - December 2003

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.

• Zorbtive Serono, Inc. - Treatment for Short Bowel Syndrome

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.

• Ertaczo Mylan Pharmaceuticals Inc. - Treatment for Tinea Pedis

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.

• Restylane Medicis - Treatment for Facial Wrinkles

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.

• Oraqix Dentsply Pharmaceutical - Treatment for Periodontal Anesthesia

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.

• Symbyax Eli Lilly - Treatment for Bipolar Depression

Symbyax (fluoxetine and olanzapine)

New Indication Approved: March 19, 2009

• FDA Approves Symbyax as First Medication for Treatment-Resistant Depression