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Linhaliq FDA 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 Timeline 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

Further information

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