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.

Date of Approval: August 12, 2005

Company: Procter & Gamble Pharmaceuticals, Inc.

Treatment for: Osteoporosis

Actonel with Calcium (risedronate sodium and calcium carbonate) 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 (nepafenac) 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 (pioglitazone and metformin) is a combination antihyperglycemic medication used in the management of type 2 diabetes.

Date of Approval: August 30, 2005

Company: Tercica, Inc.

Treatment for: Primary IGF-1 Deficiency

Increlex (mecasermin) 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 (influenza virus vaccine, inactivated) is an influenza virus vaccine indicated for adults and children (3 years and older) for the prevention of influenza disease.

New Dosage Form Approved: May 12, 2009

Patient Population Altered: October 19, 2009