The first authorized generic of Carbaglu® (carglumic acid) tablets has been made available by Eton Pharmaceuticals.

Carglumic acid is a carbamoyl phosphate synthetase 1 (CPS 1) activator approved for use in pediatric and adult patients as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthetase (NAGS) deficiency. It is also indicated in pediatric and adult patients as maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.

The product will be marketed by Eton Pharmaceuticals and is the first and only FDA-approved generic version of Carbaglu®. It was approved by the FDA for the treatment of acute and chronic hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. The product is AB-rated and is bioequivalent and therapeutically equivalent to Carbaglu®, which allows pharmacies to substitute it in place of Carbaglu® prescriptions. The product application is owned by Novitium Pharmaceuticals, a subsidiary of ANI Pharmaceuticals.

Carglumic acid is supplied as 200mg strength tablets for oral suspension in 60-count bottles. The AB-rated product is available exclusively through the specialty pharmacy, Anovo.

“We are excited to offer patients a convenient Carglumic Acid product that does not require refrigeration and to provide it at a lower price than the existing Carbaglu,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “We believe the adoption of our product will result in significant financial savings to the US healthcare system and to many patients through lower co-pay and co-insurance costs.”