
FDA approves Beximco’s generic version of MSD’s allergy drug Periactin
pharmafile | April 25, 2019 | News story | Sales and Marketing | FDA, MSD, Periactin, allergy, generics, pharma
Bangladesh-based Beximco Pharma is celebrating following the decision from the FDA to approve its generic version of MSD’s antihistamine therapy Periactin (Cyproheptadine).
The 4mg generic tablet formulation is approved in the same indications as its reference product, including the treatment of allergy symptoms such as hives, sneezing, and itchy or watery eyes or nose.
Beximco said that the total market in the US for the mediciation was around $16 million in 2018.
Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals, commented: “Cyproheptadine is our seventh product approved for the US market, and with our recent acquisition of eight ANDAs from Sandoz, our US portfolio now stands at 15 products. This approval gives us further confidence that our strategic focus and growing pipeline will strengthen our presence in the world’s largest pharma market.”
Beximco was the first Bangladeshi pharma firm to export medicines to the US in August 2016 after its oral solid dosage facility was approved by the FDA in June 2015.
Matt Fellows
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