New Drug Approvals Archive - December 2003
Zorbtive (somatropin) for Injection
Date of Approval: December 1, 2003
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.
Ertaczo (sertaconazole topical) Cream
Date of Approval: December 11, 2003
Ertaczo (sertaconazole) is an imidazole derivative antifungal indicated for the treatment of tinea pedis.
Restylane (dermal filler) Injectable Gel
Date of Approval: December 12, 2003
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.
Oraqix (lidocaine and prilocaine ) Periodontal Gel
Date of Approval: December 19, 2003
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.
Symbyax (fluoxetine and olanzapine) Capsules
Date of Approval: December 24, 2003
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 (fluoxetine and olanzapine)
New Indication Approved: March 19, 2009