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November 8, 2012
08:31 EDTCRTXCornerstone Therapeutics acquires exclusive U.S. rights to BETHKIS
Cornerstone Therapeutics announced it has entered into an agreement with Chiesi Farmaceutici S.p.A. to acquire the U.S. rights to market BETHKIS, or Tobramycin Inhalation Solution, indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia. BETHKIS received approval from the U.S. FDA on Oct. 12 and the licensing agreement with Chiesi, headquartered in Parma, Italy, was executed on Nov. 6.
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