nist inhaler available in the U.S., was first approved by the FDA a little over a year ago for use with patients 12 years or older.
The latest approval came after an FDA review of Teva data of a Phase III clinical trial that significantly better improvement in forced expiratory volume compared to placebo, the Israel-based company said.
“The prevalence of childhood asthma in the U.S. is high, at more than six million patients, and that number continues to rise,” Dr. Erwin Gelfand, pediatrics chair at National Jewish Health, said in a statement. “For this young population of asthma patients, learning to use inhalers properly can be quite challenging.”
The regulatory news comes amid Wall Street analyst expectations Teva will close on its $40.5 billion deal for Allergan’s ($AGN) generics unit in June. Pfizer ($PFE) is expected to pickup the rest of Allergan.