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Pulminiq Approval Status

FDA Approved: No
Brand name: Pulminiq
Generic name: cyclosporine
Dosage form: Inhalation Solution
Company: Chiron Corporation
Treatment for: Organ Transplant, Rejection Prophylaxis

Development Status and FDA Approval Process for Pulminiq

DateArticle
Jul 15, 2005FDA Requests Additional Data on Pulminiq (Cyclosporine, USP) Inhalation Solution; Agency Action Letter States that Pulminiq is ''Approvable'' But Additional Study is Required
Dec 15, 2004Chiron Receives FDA Priority Review Designation for New Drug Application for Pulminiq -- Cyclosporine, USP-- Inhalation Solution
Oct 14, 2004Chiron Submits New Drug Application for Pulminiq; Inhaled Form of Cyclosporine Could Be First Immunosuppressant Indicated for Chronic Lung-Transplant Rejection

Further information

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