Prilosec 1 “approvable”
This article was originally published in The Tan Sheet
Executive Summary
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)...
You may also be interested in...
MHRA omeprazole
UK medicines agency seeks comments by June 27 on reclassification of Gastro-resistant Tablets (omeprazole 10 mg) from "prescription only medicine" to "pharmacy status," according to May 16 1MHRA consultation document. Galpharm Healthcare's reclassification proposal "restricts omeprazole sale to 10 mg x 28 tablets (14-28 days treatment) and advises against long-term use without reference to the pharmacist," agency notes. Proposed P status "and pack size will also limit the indirect danger posed by the masking of serious underlying disease, which is in line with the approved dosage regimens for nonprescription omeprazole in Sweden and the USA," MHRA states. FDA has deemed AstraZeneca/P&G's Prilosec approvable for OTC use pending label revisions (2"The Tan Sheet" Aug. 26, 2002, In Brief)...
Prilosec 1 Labeling Studies Lead To Fall 2003 Launch Target
Procter & Gamble plans to introduce its nonprescription version of AstraZeneca's Prilosec (omeprazole) in the fall of 2003 based on the expectation it will obtain FDA approval for the switch in the year's third quarter
Prilosec 1 Use For GERD Endorsed In 16-2 Joint Committee Vote
Possible long-term use of omeprazole to prevent chronic heartburn or gastroesophageal reflux disease (GERD) is acceptable, despite an OTC indication for only 14-day use, FDA advisory committee members determined at a meeting in Bethesda, Md. June 21