Drug Approval | February 10, 2022
USFDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences
Adds five years of market exclusivity on approval
Adds five years of market exclusivity on approval
On track to complete the BLA submission in the first half of 2022
The Vasostrict brand market had U.S. sales of approximately US $ 878.5 million MAT for the most recent twelve months ending in December 2021 according to IQVIA Health
Nearly 1 million people are living with multiple sclerosis in the United States. Spasticity is a commonly reported symptom for MS, with an estimated prevalence of spasticity of 67%
Restasis has been approved for use in the U.S. for nearly 20 years, but until today, there was no approved generic product of this drug
Spikevax has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel
Vabysmo is the only injectable eye medicine approved simultaneously in the US for wet AMD and DME, with flexible dosing regimens based on patient need
It would be the first protein-based alternative available in Israel
Evrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to date
Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant
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