FDA Grants Temporary Importation of Pediatric Amino Acids

The FDA Drug Shortages Program has informed ASPEN that Baxter Healthcare Corporation has been granted approval for the temporary importation of Primene 10% Solution for Infusion, 250 mL, in glass container, which contains amino acids and is indicated for use in children, infants, and neonates.  This product is manufactured by Baxter’s manufacturing facility in Italy and marketed in Europe.

Clinicians should read carefully the Dear Healthcare Professional letter accompanying this imported product. It is important to note the following:

  • Primene 10% Solution for Infusion contains a different amino acid composition than amino acid solutions for pediatric patients marketed in the U.S. Primene 10% Solution for Infusion is sulfite-free. Please refer to the product comparison table at the end of the Dear Healthcare Professional letter.
  • Primene 10% Solution for Infusion contains L-Cysteine 0.189 g/100 mL as compared to 10% Premasol Sulfite-free (Amino Acid) Injection (<0.016 g/100 mL) and 6% Premasol Sulfite-free (Amino Acid) Injection (<0.014 g/100 mL).  Consider this difference when adding additional L-Cysteine to the final parenteral nutrition solution.  
  • Primene 10% Solution for Infusion is packaged in a Type II Glass Bottle with an elastomeric stopper.
  • Primene 10% Solution for Infusion has not been tested for aluminum content and this should be taken into consideration, especially when administering to preterm infants, term infants less than 1 month of age, or patients with renal impairment.
  • The Primene 10% Solution for Infusion barcode may not register accurately on the U.S. scanning systems.
  • There are some key differences in the labeling between the US FDA approved product 6% and 10% Premasol-Sulfite-free (Amino Acid) Injections and Primene 10% Solution for Infusion.  Please see the product comparison table at the end of the Dear Healthcare Professional letter.

ASPEN will continue its ongoing monitoring of this amino acids shortage. As always, ASPEN is in an advocacy role on this issue. The ASPEN staff has had many conversations and meetings with key stakeholders, including manufacturers and the FDA Drug Shortages staff to address this situation and develop feasible strategies to resolve shortages of parenteral nutrition components. We’ve also added a special lunch session on Drug Shortages including a representative from the FDA Drug Shortages Program at our ASPEN 2018 Nutrition Science & Practice Conference.