Pfizer Presses FDA To Revise Combo Drug Exclusivity Policy For Duavee
Citizen petition seeks five-year NCE exclusivity for Pfizer’s estrogen/bazedoxifene combo after district court tells FDA its inconsistent position is unreasonable.
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Court finds FDA erred in not giving the fixed-dose combo product Prepopik five years of market exclusivity since it had awarded the exclusivity to similarly situated single-entity drug products.
FDA rejects requests by firms to make new policy retroactive; Gilead’s Harvoni and Eisai’s Akynzeo fixed combos, approved the day FDA issued its final guidance, granted exclusivity.
CDC’s ACIP likely to discuss criteria needed to lift pause and whether to recommend that the vaccine not be used in specific groups. Former CBER official says FDA and CDC will look at reports for other adenovirus vector vaccines, including J&J’s Ebola vaccine, and the biological plausibility that cases of rare blood clots are directly associated with the vaccine.