The use of Prilosecl OTC for more than 14 days creates the potential
for masking of serious diseases and for delays in the treatment of
these diseases.
In order for Prosilec to be approved for OTC status AstraZeneca and
P&G had to make a change in the labeling and packaging which included
the FDA?s Nonprescription and Gastrointestinal Committees
recommendations of a course of therapy of not more than 14 days and no
more than 3 times a year.
Prilosec OTC Approval Letter
Excerpts from the Prilosec OTC Approval Letter from the FDA?s Office
of Drug Evaluation to the Proctor and Gamble Co the joint meeting of
the FDA?s:
?Nonprescription and Gastrointestinal Advisory Committees recommended
a course of therapy of not more than 14 consecutive days and no more
than 3 courses per year.?
?We are approving 28 and 42 count package sizes for this product amid
concerns that consumers follow instructions that limit duration of use
to 14 consecutive days and frequency of use to not more than 3 courses
in a given year. If you recall, much of the discussion of the June
2000 joint meeting of the Nonprescription and Gastrointestinal
Advisory Committees focused on the issue of appropriate duration and
frequency of use. The Joint Committees recommended a course of therapy
of not more than 14 consecutive days and no more than 3 courses per
year, and we have followed these recommendations. By proposing these
28- and 42 count package sizes configured as multiple 14 count units,
we feel that consumers may better understand the limitations of use.
However, it you should be interested in marketing other package
configurations in the future (..) we will expect submission of a prior
approval supplement that includes data to adequately demonstrate
appropriate consumer comprehension and limitations of use. You are
encouraged to contact the Division of Over the Counter Drug Products
about the content and format of such a supplement prior to
submission.?
Center for Drug Evaluation and Research
Jonca Bull MD ? Director / Office of Drug Evaluation V
Florence Houn MD MPH- Director / Office of Drug Evaluation V
http://www.fda.gov/cder/foi/appletter/2003/21229ltr_Prilosec.pdf
Prilosec was previously denied OTC status by FDA based on a
recommendation from the joint committees at an October 20, 2000.In the
new application, AstraZeneca and P&G have included some of the
committees? suggestions and recommended a 14-day regimen of the drug
at a once-daily 20 mg dose.
?Prilosec 1 (omeprazole) is scheduled for a second go-around with
FDA?s Nonprescription Drugs and Gastrointestinal Drugs Advisory
Committees to make the switch from Rx-to-OTC status. Manufactured by
AstraZeneca and to be marketed by The Procter & Gamble Company (P&G),
Prilosec was previously denied OTC status by FDA based on a
recommendation from the joint committees at an October 20, 2000,
meeting. At that time, the committees determined that the proposed
labeling was not sufficient to support a switch for both preventative
and episodic treatment indications for heartburn. The committees also
questioned the efficacy of the proposed 10 mg dose.?
?In the new application, AstraZeneca and P&G have included some of the
committees? suggestions and recommended a 14-day regimen of the drug
at a once-daily 20 mg dose. The companies also submitted additional
studies to FDA with the new application.
?http://www.chpa-info.org/web/newsletter/archive/2002/4_26_02_XNL.html
The Andrx Pharmaceutical Corp. submitted a CitizenPetition to the Food
and Drug Administration (?FDA?) concerning the Agency?s review of the
over-thecounter (?OTC?) version of the anti-heartburn drug omeprazole
magnesium (brand name Prilosecl), manufactured by Procter & Gamble
(?P&G?) and AstraZeneca. They claimed that that Prilosecl could not be
used safely and effectively in an OTC setting.
?The use of Prilosecl OTC for more than 14 days creates the potential
for masking of serious diseases and for delays in the treatment of
these diseases?
Read the full text of the petition here:
http://www.fda.gov/ohrms/dockets/dailys/02/Nov02/112102/02p-0493-cp00001-01-vol1.pdf
An excerpt from an FDA memorandum:
Department Of Health and Human Services
Food and Drugs Administration
Center For Drug Evaluation and Research
Division of Over-the-Counter Drug Products (HFD-560)
Date: June 20, 2003
From: Charles J. Ganley, M.D.
Director, Division of Over-the-Counter Drug Products (HFD-560)
Subject: Andrx Citizen Petition regarding Prilosec OTC (NDA 21-229)
To: Jonca Bull, M.D.
Director, Office of Drug Evaluation V
Florence Houn, M.D.
Director, Office of Drug Evaluation III
?This concern of masking more serious disease is not only applicable
to this product but to other OTC heartburn products and other
categories of OTC products. For these products, we believe this
concern has been adequately addressed by labeling. For example, other
acid reducers (e.g., H2 antagonists) are labeled for use for not more
than 2 weeks, and internal analgesics (e.g. acetaminophen,
nonsteroidal anti-inflammatory drugs) are labeled for use for not more
than 10 days.?
?The labeling and packaging for Prilosec OTC includes the following to
encourage correct use:
14 tablet package configurations to encourage use for a 14-day course;
Instructions that limit the repetitive use and the number of courses
to be used per year;18
(These instructions were added to the label as a result of the final
label comprehension study.)
Warnings that alert consumers about other symptoms that may be a sign
of a more serious condition.
(These were also added to the label as a result of the final label
comprehension study.)?
FDA
http://www.fda.gov/cder/foi/appletter/2003/21229ltr_CitizenPetition.pdf
?The Food and Drug Administration (FDA) has approved Prilosec OTC
(omeprazole), the first over-the-counter treatment for frequent
heartburn. Prilosec OTC is a delayed-release 20 mg tablet that must
be taken before eating once a day, every day for 14 days. Prilosec
OTC may take one to four days for full effect, although some consumers
may get complete relief of symptoms within 24 hours.?
FDA information on Prilosec
http://www.fda.gov/cder/drug/infopage/prilosecOTC/default.htm
FDA Approves Prilosec OTC to Treat Frequent Heartburn
http://www.fda.gov/bbs/topics/news/2003/NEW00916.html
Search criteria :
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I hope this helps!
Best regards,
Bobbie7 |
