Pharma and Biotech
By Josh White
Date: Wednesday 24 Apr 2019
LONDON (ShareCast) - (Sharecast News) - Beximco Pharmaceuticals announced on Wednesday that it has received US Food and Drug Administration (FDA) approval for its cyproheptadine hydrochloride tablet 4mg anti-allergy drug, which is a generic equivalent to 'Periactin' 4mg tablets from Merck and Company.
The AIM-traded firm described the drug as an antihistamine, used to relieve allergy symptoms such as hives, watery eyes, sneezing and itchy eyes or nose.
It said the total US market for cyproheptadine tablets was approximately $16m in 2018.
In August 2016, Beximco became the first Bangladeshi pharmaceutical company to export medicine to the US market, following the approval of its oral solid dosage facility by the FDA in June 2015.
Cyproheptadine was now Beximco's seventh abbreviated new drug application approved for the US market.
"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," said Beximco Pharmaceuticals managing director Nazmul Hassan.
"This approval gives us further confidence that our strategic focus and growing pipeline will strengthen our presence in the world's largest pharma market."
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