Carglumic acid is used in the management of rare, life-threatening inborn metabolic disorders affecting the urea cycle. It will strengthen the company’s portfolio of improved formulations for the treatment of patients suffering from inborn errors of metabolism.
CARGLUMIC ACID is used to lower the amount of ammonia in the blood of patients with N-acetylglutamate synthase deficiency. This medicine is not a cure. Compare CPS 1 activator.
Structure, properties, spectra, suppliers and links for: carglumic acid, 1188-38-1.
Carglumic acid is used together with diet and other medicines to treat and prevent hyperammonemia (too much ammonia in the blood) when it is caused by the lack of a liver enzyme called N-acetylglutamate synthase (NAGS). Ammonia is formed in the body when we digest protein. A person without the NAGS enzyme cannot process ammonia properly, and too much ammonia will collect in the blood.
Knowing the optimal dose of carglumic acid to treat your medical condition, and whether carglumic acid is safe to treat your medical condition will empower your doctor to adapt your treatment plan to suit you better. Personalised medical treatments are the future of medical practice.
Carglumic Acid Product-Specific Bioequivalence Guidance 10. 11. Disclaimer: 12. This guidance should not be understood as being legally enforceable and is without prejudice to the need to ensure that the data submitted in support of. 13. a marketing authorisation application complies with the appropriate scientific, regulatory and legal.
Carglumic acid excretion into human milk is unknown. Consider the benefits of breast-feeding, the risk of infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
CARGLUMIC ACID: 200MG: TABLET;ORAL: Prescription: None Yes: Yes: Approval Date(s) and History, Letters, Labels, Reviews for NDA 022562. Original Approvals or Tentative Approvals. Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url.