New Drug Approvals: December 2008

Date of Approval: November 28, 2008

Company: Duramed Pharmaceuticals, Inc.

Treatment for Postmenopausal Symptoms

SCE-A (synthetic conjugated estrogens, A) Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause.

Patient Population Altered: December 4, 2008

Date of Approval: December 12, 2008

Company: Eisai Corporation of North America

Treatment for Sedation

Lusedra (fospropofol disodium) is an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

Date of Approval: December 15, 2008

Company: Abbott

Treatment for Hypertriglyceridemia, Hyperlipidemia

Trilipix (fenofibric acid) is a peroxisome proliferator receptor alpha (PPARα) activator indicated for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the first and only fibrate to be approved for use in combination with a statin.

Date of Approval: December 15, 2008

Company: Genzyme Corporation

Treatment for Bone Marrow Transplantation

Mozobil (plerixafor) is a small molecule CXCR4 chemokine receptor antagonist used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.

New Dosage Regimen: December 11, 2008

Date of Approval: December 18, 2008

Company: Antisoma plc

Treatment for Chronic Lymphocytic Leukemia

Oral fludarabine (fludarabine phosphate) is an oral nucleoside analogue approved as a single agent for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL).

Labeling Revision Approved: December 12, 2008

New Indication Approved: December 19, 2008

Date of Approval: December 19, 2008

Company: NovaDel Pharma, Inc.

Treatment for Insomnia

ZolpiMist is an oral spray formulation of zolpidem, the drug contained in Ambien. ZolpiMist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Date of Approval: December 22, 2008

Company: EPIX Pharmaceuticals, Inc.

Treatment for Diagnostic

Vasovist (gadofosveset trisodium) is a blood pool magnetic resonance angiography (MRA) agent used to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.

Date of Approval: December 24, 2008

Company: Ferring Pharmaceuticals, USA

Treatment for Prostate Cancer

Degarelix is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for patients with advanced prostate cancer. Potential trade names for degarelix are still under review with the FDA.

Date of Approval: December 24, 2008

Company: Allergan, Inc.

Treatment for Hypotrichosis of Eyelashes

Latisse (bimatoprost ophthalmic) is a prostamide indicated for the treatment of hypotrichosis (or reduced amount of hair) of the eyelashes. Growth of the eyelashes is a well documented side effect of bimatoprost which is currently approved as Lumigan for the treatment of glaucoma.

Date of Approval: December 30, 2008

Company: Labopharm Inc.

Treatment for Pain

Ryzolt (tramadol HCl extended release tablets) is a once-daily analgesic indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.