July 16, 2004
IN BRIEF: SEPRACOR INC.
Sepracor Inc.'s New Drug Application for the pharmaceutical brand name drug Xopenex HFA (levalbuterol tartrate hydrofluoroalkane) Inhalation Aerosol was accepted by the Food and Drug Administration for formal review. The hydrofluoroalkane metered-dose inhaler is designed to treat or prevent bronchospasm in patients aged 4 years or older with reversible obstructive airway disease. The FDA also accepted Sepracor's resubmission of its NDA for the proprietary name drug Estorra (eszopiclone) and will complete its review of the application within six months. Estorra is intended for treating insomnia.
May 14, 2004
SEPRACOR SUBMITS NDA FOR XOPENEX HFA METERED-DOSE INHALER
Sepracor Inc. submitted a New Drug Application to the Food and Drug Administration for its pharmaceutical brand name drug Xopenex HFA (levabuterol tartrate hydrofluoroalkane) inhalation aerosol.
The HFA metered-dose inhaler (MDI) is intended to treat or prevent bronchospasm in adults, adolescents and children aged 4 years or older with reversible obstructive airway diseases such as asthma and chronic obstructive pulmonary disease.
The company's MDI research program included approximately 1,870 pediatric and adult patients enrolled in 54 preclinical and clinical trials.
Sepracor completed its Phase III trial of the brand name drug Xopenex HFA in 2003. Data showed the treatment produced statistically and clinically significant improvements in forced expiratory volume in one second (FEV1), a test of lung function that measures the amount of air forcefully exhaled in one second.
"Since MDIs are easily portable, they are generally the preferred treatment option for teenagers and adults, while nebulizer therapy is often preferred for young children and older adults for whom a nebulizer is easier to use," said Dr. Mark Corrigan, executive vice president of research and development at Sepracor.
March 26, 2004
IN BRIEF: SEPRACOR INC.
Sepracor Inc. and Ross Products Division of Abbott Laboratories have amended their agreement to co-promote the pharmaceutical brand name drug Xopenex (levalbuterol hydrochloride). The amendment changes the termination date of the agreement to Dec. 31, 2004. Sepracor said that it plans to increase its sales force from 450 to 1,250 sales professionals, eliminating the need for co-promotion. Sepracor will make residual payments to Ross totaling $33 million on or before the end of 2006.
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