![]() ![]() ![]() Food & Drug Administration ("FDA"), and Firdapse® is expected to be commercially available in the United States early in the first quarter of 2019. Catalyst's new drug application for Firdapse® (amifampridine) 10 mg tablets for the treatment of adults with Lambert-Eaton Myasthenic Syndrome (LEMS) was recently approved by the U.S. Par Pharmaceutical brought the first generic version of the powder sachet to market but at this time there is no approved generic version of the tablets.Ĭatalyst Pharmaceutical is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including LEMS, congenital myasthenic syndromes (CMS), MuSK antibody positive myasthenia gravis (MuSK-MG), and spinal muscular atrophy (SMA) type 3. Vigabatrin comes in two dosage forms – a powder sachet and a tablet. “Generic vigabatrin tablets will complement our current powder vigabatrin offering and will expand the number of patients that can benefit from having access to a high-quality, generic vigabatrin option,” said Brandon Rockwell, Senior Vice President, Business Development and Strategy of Endo. We look forward to bringing to market this important medication to improve the lives of patients.” “Our search for an appropriate partner for this product was long but rewarding with this result. McEnany, Chairman and Chief Executive Officer of Catalyst Pharmaceuticals. Endo is an established leader in the generic vigabatrin marketplace,” said Patrick J. “We are very happy to work with Endo, to bring generic Sabril ® tablets to market. Pursuant to the agreement, Catalyst will receive an up-front payment, milestone payments based on achievement of regulatory approvals, and a sharing of defined net profits upon commercialization. Generic Pharmaceuticals segment, doing business as Par Pharmaceutical. (Catalyst) (Nasdaq: CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that it has signed a Definitive Agreement with Endo International plc's (NASDAQ: ENDP) subsidiary, Endo Ventures Limited, for the further development and commercialization of generic Sabril® (vigabatrin) tablets through Endo’s U.S. 18, 2018 (GLOBE NEWSWIRE) - Catalyst Pharmaceuticals, Inc. ![]()
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