New Drug Approvals: August 2005

Date of Approval: August 12, 2005

Company: Unigene / Upsher-Smith Laboratories, Inc.

Treatment for Osteoporosis

Fortical is a nasal calcitonin formulation indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause with low bone mass relative to healthy premenopausal women.

Date of Approval: August 12, 2005

Company: Procter & Gamble Pharmaceuticals, Inc.

Treatment for Osteoporosis

Actonel with Calcium is a conveniently packaged combination of Actonel tablets (a bisphosphonate) and calcium tablets. Actonel with Calcium is a prescription therapy indicated for the prevention and treatment of postmenopausal osteoporosis.

Date of Approval: August 19, 2005

Company: Alcon, Inc.

Treatment for Postoperative Ocular Inflammation

Nevanac is a topical nonsteroidal anti-inflammatory (NSAID) and analgesic prodrug indicated for the treatment of pain and inflammation associated with cataract surgery.

Date of Approval: August 29, 2005

Company: Takeda Pharmaceuticals

Treatment for Diabetes Mellitus Type II

ACTOplus met is a combination of two widely used medications (pioglitazone and metformin) for the treatment of type 2 diabetes.

Date of Approval: August 30, 2005

Company: Tercica, Inc.

Treatment for Primary IGF-1 Deficiency

Increlex contains human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology. Increlex is indicated for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone.

Date of Approval: August 31, 2005

Company: GlaxoSmithKline

Treatment for Influenza Prophylaxis

Fluarix is an influenza virus vaccine indicated for adults 18 years and older for the prevention of influenza disease.