LONDON (Alliance News) – Circassia Pharmaceuticals PLC said Friday it submitted two applications to the US Food & Drug Administration.
The respiratory disease-focused pharmaceutical company said it submitted a new drug application to the FDA for its Duaklir Pressair, a drug to treat chronic obstructive pulmonary disease.
The company also announced submission of a supplemental new drug application Tudorza Pressair, to include clinical data supporting the cardiovascular safety in the product’s prescribing information.
Last month, Circassia reported positive test results for both drugs, developed in collaboration with FTSE 100 pharmaceutical company AstraZeneca PLC.
Circassia Chief Executive Officer Steve Harris said: “The regulatory submissions for Duaklir and Tudorza represent a major milestone for Circassia, coming just one year after we established our transformational collaboration for their commercialisation with AstraZeneca.”
Circassia shares were trading up 1.0% at 92.07 pence. AstraZeneca were up 0.6% at 5,501.00p.
By Elena Cherubini; email@example.com.
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