$CPRX Catalyst Pharmaceuticals files new drug application with FDA
Catalyst Pharmaceuticals Announces Submission of New Drug Application for Firdapse® for Treatment of Lambert-Eaton Myasthenic Syndrome
Catalyst Pharmaceuticals has submitted a new drug application (NDA) to the U.S. Food and Drug Administration, bringing the Coral Gables-based drug maker one step closer to launching Firdapse, a treatment for a rare degenerative neuromuscular disease.
Founded in 2002, Catalyst (Nasdaq: CPRX) has been working to develop Firdapse for almost a decade, a common timeline in the highly regulated pharmaceutical industry.
Firdapse aims to treats symptoms of Lambert-Eaton myasthenic syndrome, a degenerative neuromuscular disease that impacts mobility.
Last month, Catalyst announced it had earned approval from the FDA to move forward with the regulatory process to bring Firdapse to market following a failed new drug application in 2016.
The new submission, announced Thursday, addresses both issues raised by the FDA in its Refusal to File letter, sent in response to Catalyst's first new drug application for Firdapse.
"We are pleased to reach this regulatory milestone and believe that our NDA submission contains all of the necessary information to satisfy the FDA requirements," Catalyst Pharmaceuticals CEO Pat McEnany said. "This important milestone is the culmination of a strong collaboration and commitment among the patients, physicians and Catalyst employees who have worked diligently to advance Firdapse."
Regulations state that, once a new drug application is submitted, the FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing, after which time the agency will notify the company submitting the NDA of its decision.
Catalyst said it plans to communicate the agency's decision once it has been notified.
Catalyst Pharmaceuticals Announces Submission of New Drug Application for Firdapse® for Treatment of Lambert-Eaton Myasthenic Syndrome
Catalyst Pharmaceuticals has submitted a new drug application (NDA) to the U.S. Food and Drug Administration, bringing the Coral Gables-based drug maker one step closer to launching Firdapse, a treatment for a rare degenerative neuromuscular disease.
Founded in 2002, Catalyst (Nasdaq: CPRX) has been working to develop Firdapse for almost a decade, a common timeline in the highly regulated pharmaceutical industry.
Firdapse aims to treats symptoms of Lambert-Eaton myasthenic syndrome, a degenerative neuromuscular disease that impacts mobility.
Last month, Catalyst announced it had earned approval from the FDA to move forward with the regulatory process to bring Firdapse to market following a failed new drug application in 2016.
The new submission, announced Thursday, addresses both issues raised by the FDA in its Refusal to File letter, sent in response to Catalyst's first new drug application for Firdapse.
"We are pleased to reach this regulatory milestone and believe that our NDA submission contains all of the necessary information to satisfy the FDA requirements," Catalyst Pharmaceuticals CEO Pat McEnany said. "This important milestone is the culmination of a strong collaboration and commitment among the patients, physicians and Catalyst employees who have worked diligently to advance Firdapse."
Regulations state that, once a new drug application is submitted, the FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing, after which time the agency will notify the company submitting the NDA of its decision.
Catalyst said it plans to communicate the agency's decision once it has been notified.
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