Acorda gets FDA Complete Response Letter for PLUMIAZ Nasal Spray NDA Acorda Therapeutics.

We are focused on the commercialization and advancement of PLUMIAZ, a potential therapeutic choice for these individuals,’ stated Ron Cohen, M.D., Acorda's President and CEO. ‘We are evaluating the Complete Response Letter and expect to work carefully with the FDA to address the items outlined in the letter and refile the NDA for PLUMIAZ. We be prepared to provide further fine detail as our discussions with the FDA progress.’ Related StoriesUnderstanding the sources of sudden death in epilepsy: an interview with Professor Sanjay SisodiyaTARSA Therapeutics' TBRIA NDA accepted by FDA for reviewAllergan settles patent litigation with Amneal related to NAMENDA XR prolonged release capsulesBased on the requirements for authorization outlined in the letter, the ongoing company does not expect PLUMIAZ to get FDA approval in 2014.Wasserman, M.D., Michael J. Walter, M.D., Michael E. Wechsler, M.D., Vernon M. Chinchilli, Ph.D., and Eugene R. Bleecker, M.D. For the National Heart, Lung, and Bloodstream Institute Asthma Clinical Research Network: Tiotropium Bromide Step-Up Therapy for Adults with Uncontrolled Asthma Many adults with asthma have inadequate control of symptoms when finding a low-to-moderate dose of an inhaled glucocorticoid.1,2 Treatment plans include the addition of a leukotriene modifier,2 the addition of a long-performing beta-agonist ,2-4 or an increased dosage of an inhaled glucocorticoid.2 Current suggestions of the National Asthma Education and Prevention Program favor the last two options.2 In latest communications, however, the meals and Medication Administration 5 and asthma experts6,7 possess questioned the safety of LABA therapy and suggested strategies to minimize the usage of these drugs.