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Spiriva Approval History

  • FDA approved: Yes (First approved January 30th, 2004)
  • Brand name: Spiriva
  • Generic name: tiotropium bromide
  • Dosage form: Inhalation Powder
  • Company: Boehringer Ingelheim
  • Treatment for: COPD, Maintenance

Spiriva HandiHaler (tiotropium bromide) is an anticholinergic indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations.

Development History and FDA Approval Process for Spiriva

Dec 18, 2009Approval FDA Approves Spiriva HandiHaler for the Reduction of COPD Exacerbations
Jan 30, 2004Approval Spiriva HandiHaler Boehringer Ingelheim - Treatment for Chronic Obstructive Pulmonary Disease (COPD)

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