Beximco Pharmaceuticals Limited, one of the leading medicine manufacturers and exporters in the country, has received US Food and Drug Administration (FDA) approval for Baclofen (10 and 20 mg tablets), a muscle relaxant drug indicated for the treatment of muscle pain, spasms, and stiffness in people with multiple sclerosis or spinal cord injury or disease.
This is Beximco Pharma's ninth Abbreviated New Drug Application (ANDA) fully developed in-house and successfully approved for the US market since the company's oral solid dosage facility was approved by the US FDA in June 2015, reads a press release.
The company expects to launch the product through its US distribution partner in due course.
According to IQVIA audited market data, there are currently nine active players for Baclofen in the US market, which generated sales of more than US$ 110 million in 2020.
Mr Nazmul Hassan MP, managing director of Beximco Pharmaceuticals, said, "We are pleased to have received FDA approval of Baclofen, a commonly prescribed medicine in the US, as we continue to leverage our core strengths in R&D and manufacturing to develop and deliver important generic products to patients."
"This approval strengthens our product offering in the US and we look forward to the launch of generic Baclofen in due course," he continued.