. 

No. 973

TO:

FROM:

RE:

having difficulty i
pointed out that the FDA must indicat
use by the public can be formulated.

GlPoos
TNGates
SMGreenberg
LGMillstein
Res. Div. Off.
WRJones
GFWortham
LRGagnon
ARFurg iuele
CKCain

PHSeay



P25730001

REGULATORY AFFAIRS
LABORATORIES, INC.

HWM cNey


FElse
JEO'Brien

WLMadison
JCMaerz
RLLeininger
RJBrenner
CFKade
Central Files

8 June 1973

Original - Vault

On 22 March 1973. Dr. Dassler indicated that the FDA was

approving the TYLENOL-SOO capsules for Rx status. She
a product OTC if directions for safe
I told her that we would not object if

the approval was for OTC status (See memo 939). My statement on accept-
ance of OTC status was based on the decision reached at New Products Com-

mittee).

Laboratories regarding OTC or Rx status of TYLENOL-SOO capsules.

meeting was

was decided that the FDA should be requested to

We recieved a letter on 17 May 1973 from the FDA indicating
that the NDA on TYLENOL-500 capsules is adequate and that we should sub-
mit draft labeling for OTC use.

On 5 June. a meeting was held to dis cuss the position of McNeil

The

attended by Kip, Else, Gagnon, O'Brien, McGann and Seay. It

reconsider this matter and

approve labeling for TYLENOL-SOO capsules for Rx status. It was agreed
that the vast majority of patients are receiving adequate therapy with the
present dosage recommendations and we believe it is unnecessary to recom-
mend higher dosage to the public.

NI
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No. 973 - Page 2. 8 June 1973

I talked with Dr. Dassler on 7 June. I told her that we had
received the FDA letter on 17 May and that we would like for the FDA to re-
consider their decision on OTC labeling; we would like to have it indicated
for Rx status. In the first place, the Code of Federal Regulations specifies
that for OTC use tablets of 325 mg. of acetaminophen will be used in a
maximum daily dose of Z. 6 grams. As our unit dosage is 500 mg. and the
maximum daily dose is 4. 0 grams, we will be in violation of the regulations.

More important than the regulations, which could be changed,
the vast majority of patients, probably 98%, are effectively treated with the
product using the present labeling for dosage administration. We believe it
is unnecessary to recommend higher amounts to the public. We realize
that some individuals probably are using higher amounts than are currently
recommended. However, if the recommended dosage is increased, the same
individuals who are exceeding present recommendations will also exceed the
new higher recommendations.

For those few patients who are not being effectively treated with
the present recommended dosage of acetaminophen, they probably should be
under the supervision of a physician and adequate dosage recommendations
should be available. We know that 4. 0 grams per day is safe and we believe
that patients are more likely to adhere to a dosage regimen prescribed by a
physician than if it is OTC. For these reasons, we request that TYLENOL-SOO
capsules be approved Rx.

Dr. Dassler was very definite in her view that the FDA would
not approve TYLENOL-SOO capsules Rx. The FDA has asked us to submit
appropriate OTC labeling. If the present labeling provided by the regulations
is adequate, then 5 capsules per day would be appropriate. However, if this
dosage form is being provided so the physician can indicate dosage higher
than is currently recommended in the regulations, the physician is free now
to prescribe 3 tablets and the total daily dosage that is necessary for adequate
therapy. Dr?. Beaver concurred in this opinion. I told Dr. Dassler that we
may want to submit Rx labeling for reconsideration by the FDA. She said that
this will simply prolong approval of the OTC labeling.

d7

V15. ?say



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