FDA approves Beximco Pharma’s muscle relaxant drug Baclofen

pharmafile | July 26, 2021 | News story | Sales and Marketing  

Beximco Pharma has received FDA approval for Baclofen (10 and 20 mg tablets).

Baclofen is a muscle relaxant drug indicated for the treatment of muscle pain, spasms, and stiffness in people with multiple sclerosis, spinal cord injury, or disease.

This is Beximco Pharma’s ninth Abbreviated New Drug Application 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.

According to IQVIA audited market data, there are currently nine active players for Baclofen in the US market, which generated sales of more than $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.”

Beximco Pharma is a manufacturer and exporter of medicines based in Bangladesh.

Lilly Subbotin

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