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BSS-65
BEXIMCO-US-APPROVAL
Beximco Pharma gets US FDA approval for Cyproheptadine
DHAKA, April 24, 2019 (BSS) – Beximco Pharmaceuticals Limited (BPL) has
received US Food and Drug Administration (FDA) approval for anti-allergy drug
“Cyproheptadine Hydrochloride” Tablet (4 mg), which is a generic equivalent
to Periactin(r)Tablets (4 mg) from Merck and Company, Inc.
BPL today announced this latest outcome through a media statement, as
Cyproheptadine is Beximco’s seventh Abbreviated New Drug Application (ANDA)
approved for the US market, said a press release here.
Cyproheptadine is an antihistamine used to relieve allergy symptoms such
as hives, watery eyes, sneezing and itchy eyes or nose.
In August 2016, Beximco Pharma became the first Bangladeshi
pharmaceutical company to export medicine to the US market, following the
approval of its oral solid dosage facility by the US FDA in June 2015.
BPL Managing Director Nazmul Hassan, MP, said, “This approval gives us
further confidence that our strategic focus and growing pipeline will
strengthen our presence in the world’s largest pharma market.”
The Company currently has a global footprint in more than 50 countries
and has been accredited by leading global regulatory authorities including
the US FDA, AGES (EU), TGA (Australia), Health Canada, GCC (Gulf) and TFDA
(Taiwan).
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