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Linhaliq Approval Status

FDA Approved: No
Brand name: Linhaliq
Generic name: ciprofloxacin liposomal
Dosage form: for Inhalation
Company: Aradigm Corporation

Linhaliq is an inhalation formulation of liposome encapsulated and unencapsulated ciprofloxacin in development for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa.

Non-Cystic Fibrosis Bronchiectasis

Development Status and FDA Approval Process for Linhaliq

DateArticle
Jan 29, 2018Aradigm Receives Complete Response Letter from the FDA for Linhaliq NDA
Sep 25, 2017Aradigm Announces FDA Acceptance of NDA for Linhaliq with Priority Review Status
Jul 27, 2017Aradigm Submits New Drug Application (NDA) to FDA for U.S. Marketing Approval of Linhaliq in Non-Cystic Fibrosis Bronchiectasis
Nov 19, 2012UK Scientists Report on Efficacy of Aradigm's Lipoqui Against Pneumonic Plague
Oct 16, 2012Virginia Commonwealth University Scientists Report Anti-Inflammatory Effect of Aradigm's Inhaled Liposomal Ciprofloxacin
Sep 20, 2012UK Scientists Report Successful Testing of Aradigm's Inhaled Liposomal Ciprofloxacin in Q Fever
Sep 21, 2011Aradigm Presents Additional Analyses of the Clinical Results From ORBIT-1 and ORBIT-2 Trials of Inhaled Ciprofloxacin at the 2011 European Respiratory Society (ERS) Annual Congress
Jun 16, 2011Aradigm Reports Successful ORBIT-1 Bronchiectasis Study with Inhaled Liposomal Ciprofloxacin
Oct 20, 2010Aradigm Reports Successful Phase 2b Bronchiectasis Study with Inhaled Liposomal Ciprofloxacin

Further information

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