Mayne Pharma obtains FDA blessing for chlorzoxazone
The Food and Drug Administration has approved Mayne Pharma’s chlorzoxazone tablets. The company said it had commenced commercial launch activities in the United States.
Mayne Pharma's generic, which was approved in dosage strengths of 375 mg, 500 mg and 750 mg, is a muscle relaxant indicated to treat painful, acute musculoskeletal conditions alongside rest, physical therapy and other measures.
"This launch reinforces Mayne Pharma's commitment to expanding our on-market portfolio with high-quality generic products and delivering affordable medicines to our patients," said Scott Richards, CEO of Mayne Pharma. "Chlorzoxazone was developed internally and will be manufactured at our Greenville, N.C. manufacturing facility."
Chlorzoxazone had a market value of approximately $25 million for the 12 months ended May 31, according to IQVIA.