New Drug Approvals Archive - 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.

• Atripla Bristol-Myers Squibb Company / Gilead Sciences, Inc. - Treatment for HIV-1 Infection

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.

• Implanon Organon - Treatment for Contraception

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.

• AstraZeneca’s Symbicort (budesonide/formoterol) Treatment For Asthma Approved By The FDA

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).

• Elaprase Shire plc - Treatment for Hunter Syndrome

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.

• Xolegel Gel Barrier Therapeutics, Inc. - Treatment for Seborrheic Dermatitis

Xolegel (ketoconazole) FDA Approval History

Keppra (levetiracetam)

New Dosage Form Approved: July 31, 2006

• FDA Approves Keppra Injection

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 Takeda Pharmaceuticals North America, Inc. - Treatment for Type 2 Diabetes

Duetact (pioglitazone HCl and glimepiride) FDA Approval History

Humira (adalimumab)

New Indication Approved: July 31, 2006

• Humira Receives FDA Approval for Treatment of Ankylosing Spondylitis

Symbicort (budesonide and formoterol)

New Indication Approved: February 27, 2009

• FDA Approves Symbicort for Chronic Obstructive Pulmonary Disease (COPD)

Symbicort (budesonide and formoterol) FDA Approval History

Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate)

Labeling Revision Approved: January 7, 2010

• HIV/AIDS Update - Atripla label update reflects new efficacy, safety and resistance data in treatment experienced patients

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

Symbicort (budesonide and formoterol)

Patient Population Altered: January 27, 2017

• Symbicort Approved for the Treatment of Asthma in Patients 6 to 12 Years of Age

Symbicort (budesonide and formoterol) FDA Approval History