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New Drug Approvals Archive - August 2005

August 2005

Fortical (calcitonin) Nasal Spray

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.

Actonel with Calcium (risedronate sodium and calcium carbonate)

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.

Nevanac (nepafenac) Ophthalmic Suspension

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.

ACTOplus met (pioglitazone and metformin) Tablets

Date of Approval: August 29, 2005
Company: Takeda Pharmaceuticals
Treatment for: Diabetes Type 2

Actoplus met (pioglitazone and metformin) is a combination antihyperglycemic medication used in the management of type 2 diabetes.

Increlex (mecasermin) Injection

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.

Fluarix (influenza virus vaccine, inactivated)

Date of Approval: August 31, 2005
Company: GlaxoSmithKline
Treatment for: Influenza Prophylaxis

Fluarix (influenza virus vaccine, inactivated) is an influenza virus vaccine indicated for the prevention of influenza.

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