New Drug Approvals: July 2006

Company: ZARS Pharma

Treatment for Topical Local Anesthesia

Date of Approval: July 12, 2006

Company: Bristol-Myers Squibb Company / Gilead Sciences, Inc.

Treatment for HIV Infection

Atripla is a once-daily single tablet regimen combining the non-nucleoside reverse transcriptase inhibitor Sustiva (efavirenz), and the nucleoside reverse transcriptase inhibitors Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate). Atripla is indicated as a stand-alone therapy or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults.

Date of Approval: July 18, 2006

Company: Organon

Treatment for Contraception

Implanon is a single-rod subdermal implant that continually releases a low, steady dose of progestin (etonogestrel) providing contraceptive effectiveness for a period of up to three years.

Date of Approval: July 24, 2006

Company: Shire plc

Treatment for Mucopolysaccharidosis Type II

Elaprase is a purified form of the human lysosomal enzyme iduronate-2-sulfatase produced by recombinant DNA technology. Elaprase is indicated for the treatment of Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II).

Date of Approval: July 28, 2006

Company: Barrier Therapeutics, Inc.

Treatment for Seborrheic Dermatitis

Xolegel is a topical waterless gel formulation of the antifungal agent ketoconazole, applied once-daily for the treatment of seborrheic dermatitis in immunocompetent adults and children twelve years of age and older.

New Dosage Form Approved: July 31, 2006

Date of Approval: July 31, 2006

Company: Takeda Pharmaceuticals North America, Inc.

Treatment for Diabetes Mellitus Type II

Duetact is a combination of pioglitazone, which directly targets insulin resistance, and glimepiride, a sulfonylurea that acts primarily by increasing the amount of insulin produced by the pancreas. Duetact is indicated for the treatment of type 2 diabetes.

New Indication Approved: July 31, 2006