Israël – FDA accepts Teva’s NDA for albuterol MDPI

July 16, 2014 3:43 pm0 commentsViews: 48
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Israel-based generic giant Teva Pharmaceuticals Industries (NYSE: TEVA) says that the US Food and Drug Administration has accepted for review the company’s New Drug Application for albuterol multi-dose dry-powder inhaler (MDPI).

This is an investigational breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm (EIB) in patients 12 years of age and older.

TEVA’S ALBUTEROL WOULD FILL UNMET NEED IN USA

“If approved, albuterol MDPI would become the first breath-actuated dry-powder symptomatic and rescue inhaler available to asthma patients,” said Tushar Shah, senior vice president, Teva Global Respiratory R&D, adding: “As the current market-leader in asthma rescue inhalers, it is our hope that the new dry-powder innovation utilized with albuterol MDPI will help fill an unmet need in the existing asthma market.”

The NDA filing includes data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in adults and adolescents (12 years of age and older) with asthma and exercise-induced bronchospasm (EIB). The NDA for albuterol MDPI has been accepted by the FDA for standard review, with a FDA Regulatory Action expected in March 2015.

[Source: NASDAQ]

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