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Tudorza Approval History

FDA Approved: Yes (First approved July 23, 2012)
Brand name: Tudorza
Generic name: aclidinium bromide
Dosage form: Pressair
Company: Allergan plc
Treatment for: COPD

Tudorza Pressair (aclidinium bromide inhalation powder) is an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Development History and FDA Approval Process for Tudorza

DateArticle
Jul 23, 2012Approval FDA Approves Tudorza Pressair to Treat Chronic Obstructive Pulmonary Disease
Feb 24, 2012Forest and Almirall Announce Positive FDA Advisory Committee's Recommendation for Approval of Aclidinium Bromide for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Jun 30, 2011Forest and Almirall Announce Submission of New Drug Application for Aclidinium Bromide for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Further information

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