Prilosec Rx-to-OTC switch
AstraZeneca/Proctor & Gamble's Prilosec (omeprazole) prescription to over-the-counter application for prevention of symptoms of frequent heartburn will be reviewed by FDA's Nonprescription Drugs and Gastrointestinal Drugs Advisory Committees June 21. The committees previously voted against a switch for episodic treatment of heartburn but left the prevention claim open (1"The Pink Sheet" Oct. 23, 2000, p. 24). The revised application is for once-daily 20 mg for 14 days. The meeting will be held at the Holiday Inn in Bethesda, Md. at 8 a.m. (Sign up for a webcast at 2FDAAdvisoryCommittee.com)...
You may also be interested in...
Gastroesophageal reflux disease is appropriate for OTC treatment, but AstraZeneca/Procter & Gamble's NDA to switch Prilosec OTC is not approvable, FDA's Nonprescription and Gastrointestinal Drugs Advisory Committees voted at a joint meeting Oct. 20.
VMS businesses are deemed essential in Department of Homeland Security guidance that provides as basis for orders by most states and localities across the US. During an AHPA webinar, attorney Trent Norris says the federal government prefers leaving business exemptions to shut-down decisions to the states.
Company expects clinical trials to begin by September and says first batches could be available for emergency use authorization in early 2021; J&J pledges vaccine will be available to public on not-for-profit basis.