US FDA approves Beximco Pharma’s Nadolol tablets

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Business Desk :
Beximco Pharmaceuticals Limited has received US Food and Drug Administration (FDA) approval for its Nadolol tablets (20mg, 40mg and 80mg), which are generic equivalent of Bristol-Myers Squibb’s Corgard tablets, for treating hypertension (high blood pressure) and angina pectoris (chest pain), said a press release.
 This is Beximco Pharma’s fifth Abbreviated New Drug Application (ANDA) approved for the US market since the Company’s oral solid dosage facility was approved by the US FDA in June 2015. Beximco Pharma expects to launch the product through its US distribution partner, Bayshore Pharmaceuticals LLC. According to IQVIA market data (MAT March 2018), the estimated market for for Nadolol tablets in the US is currently valued at USD 71 million.
Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals, commented:
“We are delighted to have received our fifth product approval for the US market. Beximco Pharma remains the only Bangladeshi company to export medicines to the US, which is a validation of our expertise in offering specialized generic products in a global setting.
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