New Drug Approvals Archive - July 2006
Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets
Date of Approval: July 12, 2006
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.
Implanon (etonogestrel) Implant
Date of Approval: July 18, 2006
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.
Symbicort (budesonide and formoterol) Inhaler
Date of Approval: July 21, 2006
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.
Elaprase (idursulfase) Injection
Date of Approval: July 24, 2006
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).
Xolegel (ketoconazole) Gel - formerly Sebazole
Date of Approval: July 28, 2006
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
Duetact (pioglitazone HCl and glimepiride) Tablets
Date of Approval: July 31, 2006
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
Symbicort (budesonide and formoterol)
New Indication Approved: February 27, 2009
Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate)
Labeling Revision Approved: January 7, 2010