News | January 25, 2022
USFDA rejects Merck’s gefapixant; gain approval in Japan
Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant
Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant
The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US
The recommended daily dose for Ryaltris is 2 sprays in each nostril twice daily
This surpasses the number of approvals supported in 2020
The product will be marketed under store brand labels and is comparable to the brand Zyrtec
Dronedarone tablets USP, 400 mg have an estimated market size of US $ 500 million for twelve months ending September 2021 according to IQVIA
JBI-802 is a novel, oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6
Entacapone tablets USP, 200 mg have an estimated market size of US$ 10.5 million for twelve months ending September 2021, according to IQVIA
Doxycycline Hyclate Delayed Release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
The current annual U.S. market for amphetamine mixed salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg immediate release tablets strengths is approximately US $ 335 million, according to MAT, Oct 2021 IQVIA/IMS Health
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