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July 2006

July 12

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.

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

July 18

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.

Implanon (etonogestrel) FDA Approval History

July 21

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.

Symbicort (budesonide and formoterol) FDA Approval History

July 24

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).

Elaprase (idursulfase) FDA Approval History

July 28

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.

Xolegel (ketoconazole) FDA Approval History

July 31

Keppra (levetiracetam)

New Dosage Form Approved: July 31, 2006

July 31

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.

Duetact (pioglitazone HCl and glimepiride) FDA Approval History

July 31

Humira (adalimumab)

New Indication Approved: July 31, 2006

February 27

Symbicort (budesonide and formoterol)

New Indication Approved: February 27, 2009

Symbicort (budesonide and formoterol) FDA Approval History

January 11

Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate)

Labeling Revision Approved: January 7, 2010

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

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