API crystals foul Hospira cancer drug

Hospira sent a letter on Monday to tell healthcare professionals about crystallization in some lots of the chemotherapy drug Cytarabine. The specialty drugmaker determined the crystals are particles of the API.

Hospira, which has corrected the problem, says a root cause analysis indicates dried Cytarabine on filling needles as the most likely cause. Particles may enter the vials during production and then seed crystal formation.

Cytarabine, both powder for reconstitution and the solution form, is among drugs in short supply, according to the FDA. Shortages are currently listed by the three makers of the drug: Hospira, Bedford Labs and APP Pharmaceuticals. API shortage and manufacturing delays are listed as causes.

- see the letter
- here's the Drug Shortage list update


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.