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New Drug Approvals Archive - July 2006

July 2006

Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets

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.

Read more: Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) FDA Approval History

Implanon (etonogestrel) Implant

Date of Approval: July 18, 2006
Company: Organon
Treatment for: Contraception

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

Read more: Implanon (etonogestrel) FDA Approval History

Symbicort (budesonide and formoterol) Inhaler

Date of Approval: July 21, 2006
Company: AstraZeneca
Treatment for: Asthma -- Maintenance, Chronic Obstructive Pulmonary Disease -- Maintenance

Symbicort (budesonide and formoterol) is a combination of a corticosteroid and a long-acting bronchodilator indicated for the long-term maintenance treatment of asthma and the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Read more: Symbicort (budesonide and formoterol) FDA Approval History

Elaprase (idursulfase) Injection

Date of Approval: July 24, 2006
Company: Shire plc
Treatment for: Mucopolysaccharidosis Type II

Elaprase (idursulfase) 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).

Read more: Elaprase (idursulfase) FDA Approval History

Xolegel (ketoconazole) Gel - formerly Sebazole

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.

Read more: Xolegel (ketoconazole) FDA Approval History

Keppra (levetiracetam)

New Dosage Form Approved: July 31, 2006

Duetact (pioglitazone HCl and glimepiride) Tablets

Date of Approval: July 31, 2006
Company: Takeda Pharmaceuticals North America, Inc.
Treatment for: Diabetes Type 2

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.

Read more: Duetact (pioglitazone HCl and glimepiride) FDA Approval History

Humira (adalimumab)

New Indication Approved: July 31, 2006

New Drug Approvals Archive