New Drug Approvals: October 2004

Date of Approval: October 8, 2004

Company: Serono, Inc.

Treatment for Female Infertility

Luveris is a recombinant human form of luteinizing hormone approved for concomitant use with Gonal-f (follitropin alfa for injection) for stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency.

Company: Valera Pharmaceuticals

Treatment for Prostate Cancer

Date of Approval: October 13, 2004

Company: Inamed Corporation and Genzyme Corporation

Treatment for Wrinkle Correction

Hylaform Plus is a large particle size hyaluronic acid-based dermal filler that is indicated for the correction of moderate to severe facial wrinkles and folds.

Date of Approval: October 18, 2004

Company: Eisai Inc.

Treatment for Alzheimer's Disease

Aricept ODT is a disintegrating tablet dosage form designed to make administration easier for patients with Alzheimer’s disease. Studies have shown these patients may develop difficulty with swallowing.

Date of Approval: October 19, 2004

Company: Sanofi Aventis US

Treatment for Allergic Rhinitis, Nasal Congestion

Allegra-D 24 Hour is a once daily prescription antihistamine and decongestant formulation approved for the treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older.

Company: J & J Pharmaceuticals

Treatment for Bacterial Infections

Date of Approval: October 22, 2004

Company: Connetics Corporation

Treatment for Acne

Evoclin (formerly referred to as Actiza) is 1% clindamycin delivered in Connetics’ proprietary VersaFoam vehicle. Evoclin is indicated for the topical treatment acne vulgaris.

Date of Approval: October 26, 2004

Company: Amphastar Pharmaceuticals, Inc

Treatment for Adjuvant to increase the absorption and dispersion of other injected drugs

Amphadase (formulated as a replacement for Wydase which was discontinued in 2001) contains hyaluronidase, an enzyme that breaks down hyaluronic acid in connective tissue, increasing tissue permeability. Hyaluronidase is typically used as an adjunctive agent to facilitate the dispersion and absorption of other drugs.

Date of Approval: October 26, 2004

Company: Shire Pharmaceuticals Group plc

Treatment for Hyperphosphatemia of Renal Failure

Fosrenol is a non-calcium, non-aluminum phosphate binder formulated as an easy to use, chewable only tablet that can be taken without water. Fosrenol is used to reduce high phosphorus levels in end-stage renal disease (ESRD) patients.