FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Pegademase bovine (Adagen) Injection
Status: Discontinuation
»Therapeutic Categories: Other; Pediatric

Leadiant Biosciences, Inc. (New 01/18/2019)

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Presentation Posting Date Related Information
ADAGEN (pegademase bovine) Injection 250 units per mL (NDC 57665-001-01) 01/18/2019 The discontinuation of the manufacture of Adagen is due to the permanent shortage of the active ingredient. The discontinuation of the product is not due to product quality, safety, or efficacy concerns. Based on the demand in mid-January 2019, the inventory is estimated to runout by late-March 2019. Physicians can continue to treat ADA-SCID patients with another approved treatment for ADA-SCID.

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