FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Canakinumab (Ilaris) Lyophilized Powder for Injection
Status: Discontinuation
»Therapeutic Categories: Pediatric; Rheumatology

Novartis (New 04/27/2017)

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Presentation Posting Date Related Information
ILARIS (canakinumab) 150 mg/vial lyophilized powder for injection (For subcutaneous use)(NDC 0078-0582-61) N/A Novartis Pharmaceuticals has made a business decision to permanently discontinue ILARIS (canakinumab), 150 mg lyophilized powder in single-dose vials for reconstitution. This decision was not related to efficacy, safety, or quality. The ILARIS (canakinumab) 150 mg lyophilized powder formulation should be available on the U.S. market until approximately September 2017 - January 2018. ILARIS (canakinumab) 150 mg/mL Injection (solution) NDC #0078-0734-61 for subcutaneous use is replacing the ILARIS (canakinumab) 150 mg for Injection (lyophilized powder) dosage form and is already available in the U.S. market. ILARIS (canakinumab) 150 mg/mL Injection (solution) is a reconstitution-free liquid, supplied in single-dose vials for subcutaneous injection by a healthcare professional.

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