ADELAIDE, Australia, July 27, 2020 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug Administration (FDA) has granted approval of its Abbreviated New Drug Application (ANDA) for chlorzoxazone tablet, 375 mg, 500 mg and 750 mg, in the United States. Mayne Pharma has commenced commercial launch activities to customers in the US.
Chlorzoxazone in tablet form is a fast-acting muscle relaxant that is indicated, along with rest, physical therapy and other measures, for painful acute musculoskeletal conditions. According to IQVIA, US sales of chlorzoxazone were approximately US$25 million for the 12 months ending 31 May 2020.
Mayne Pharma's CEO Scott Richards said, "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. Chlorzoxazone was developed internally and will be manufactured at our Greenville, North Carolina manufacturing facility."
Mayne Pharma directly markets more than 60 generic and specialty branded pharmaceuticals in the United States.
About Mayne Pharma
Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on applying its drug delivery expertise to commercialise branded and generic pharmaceuticals, offering patients better and more accessible medicines. Mayne Pharma also provides contract development and manufacturing services to more than 100 clients worldwide.
Mayne Pharma has a 40-year track record of innovation and success in developing new oral drug delivery systems and these technologies have been successfully commercialised in numerous products that continue to be marketed around the world.
Mayne Pharma has two facilities based in Salisbury, Australia and Greenville, USA with expertise in the formulation of complex oral and topical dose forms including potent compounds, modified-release products and poorly soluble compounds.
Safety information
Chlorzoxazone-containing products are usually well tolerated. Drowsiness, dizziness, light-headedness, malaise, or overstimulation may be noted by an occasional patient. The concomitant use of alcohol or other central nervous system depressants may have an additive effect.
Chlorzoxazone is contraindicated in patients with known intolerance to the drug. Chlorzoxazone should be used with caution in patients with known allergies or with a history of allergic reactions to drugs. If any symptoms suggestive of liver dysfunction are observed, the drug should be discontinued.
For complete prescribing information and important safety information please visit here
To report a suspected adverse reaction from one of our products, please contact Mayne Pharma at 1-844-825-8500 or maynepharmamc@dlss.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.