ANI and Eton Pharmaceuticals make Carglumic Acid Tablets Available

Carglumic Acid tablets have been commercially launched by Eton Pharmaceuticals Inc., an innovative pharmaceutical company focused on developing and commercialising treatments for rare diseases, and ANI Pharmaceuticals Inc., a biopharmaceutical company serving patients in need through the development and manufacturing of high-quality generic and branded medicines. Eton Pharmaceuticals will market the medicine, which is the first and only FDA-approved generic version of Carbaglu®.

The FDA approved it for the treatment of acute and chronic hyperammonemia caused by a lack of N-acetylglutamate synthase. The product has an AB rating and is bioequivalent and medically equivalent to Carbaglu®, allowing pharmacies to fill Carbaglu® prescriptions with it instead. Novitium Pharmaceuticals, a subsidiary of ANI Pharmaceuticals, owns the product application. The FDA approved the product application Competitive Generic Therapy (CGT) classification, which means the product will have 180 days of generic exclusivity.

“This approval reinforces ANI’s specific focus and maintains our leading position in Competitive Generic Therapy approvals,” stated Nikhil Lalwani, CEO of ANI Pharmaceuticals. Anovo, a specialised pharmacy dedicated to treating people with rare and chronic diseases, is the only place to get Carglumic Acid tablets. In collaboration with Eton Pharmaceuticals, Anovo will manage the Eton Cares Program. Prescriptions will be filled, insurance benefits will be investigated, educational support will be provided, and qualified patients will be assisted in obtaining financial assistance, among other services geared to help patients get treatment.

Eton Cares will provide co-pay help to eligible patients, allowing them to pay no co-pays. Eton Pharmaceuticals, Inc. is a cutting-edge pharmaceutical business specialising in the development and marketing of therapies for rare disorders. Six FDA-approved products, including ALKINDI SPRINKLE®, Carglumic Acid, Biorphen®, Alaway® Preservative Free, Rezipres®, and EprontiaTM, are owned or receive royalties by the company, and four additional items have been submitted to the FDA.