Tuesday, February 18, 2020

Tuesday, February 18, 2020

U.S. FOOD AND DRUG ADMINISTRATION: Belatacept (Nulojix) Lyophilized Powder for Injection

U.S. Food and Drug Administration recently issued the following announcement. 

Belatacept (Nulojix) Lyophilized Powder for Injection

Status: Currently in Shortage

»Date first posted: 03/06/2017

»Therapeutic Categories: Transplant

Bristol Myers Squibb Co. (Revised 07/27/2018)

Company Contact Information: 800-721-5072 ; 877-417-1523

Presentation: 20cc vial 250mg lyophilized powder per vial for IV infusion (NDC 0003-0371-13)

Availability and Estimated Shortage Duration: No disruption to existing patients is anticipated. Until further notice, BMS will continue to limit distribution of NULOJIX via the US NULOJIX Distribution Program, initiated 15-Feb-2017. Starting in August 2018, the restrictions of the NDP will be eased to allow for expansion of use to appropriate new patients if the treating physician determines that Nulojix is the best treatment option for the patient. For further information, contact BMS Medical Information.

Related Information: Increased demand for the drug exacerbated by a delay in transition to a more efficient manufacturing process.

Shortage Reason (per FDASIA): Demand increase for the drug

Original source can be found here.

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U.S. Food and Drug Administration

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