Prilosec 1 “approvable”
P&G expects final approval of OTC Prilosec (omeprazole) for prevention of frequent heartburn early in the first quarter of 2003, firm says following Aug. 8 FDA letter deeming drug "approvable" pending label modifications and a label comprehension study. Company says FDA's correspondence gives it a "much better understanding of what is needed in a label comprehension study." In June, agency advisory committee members voted 16-2 in favor of switching the proton pump inhibitor OTC, but recommended significant labeling changes and an additional comprehension study (1"The Tan Sheet" June 24, 2002, p. 3). FDA's letter came three days after P&G told analysts during its Aug. 5 fiscal year-end earnings call that it hoped for final OTC approval before 2003 (2"The Tan Sheet" Aug. 12, 2002, p. 7)...
Learn what's happening at the US FDA. On the go.
More from Archive
- • By
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
- • By
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
More from Pink Sheet
- • By
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
- • By
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
- • By
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
