f--J MERCK

,.~
f--J
MERCK
‘,
October
Food and Drug
5630
Fishers
Room
1061
Rockville,
22,
1999
Administration
Lane
MD
20852
DOCKET
NO. 98 N-0337
NDA
Pepcid
20-902
AC Gelcaps
APPLICATION
{Famotine
10 mg)
FOR EXEMPTION
Dear Sir or Madam:
Please
Also
refer
refer
pouch
be
to
our
package
this
whose
20-902
being
with
an
standardized
time
we
contents
justificati~n
for
submission
was
resubmitted
labeling
At
to NDA
of July
deleted
2,
from
consist
granting
Gelcaps
19999
the
New
request
approved
which
Drug
for
on August
indicated
that
Application
5, 1999.
the
sample
but that
an exemption
from
it would
the
OTC
requirements.
are submitting
for
AC
accompanying
format
will
Pepcid
this
application
of one Pepcid
the
draft
exemption,
for
exemption
AC Gelcap,
This
labeling,
for
a sample
application
annotated
pouch
consists
and
of
current
labeling.
If there
Edwin
are
any
Hemwall,
questions,
please
call
me
at (21 5) 273-7152
or in my
PhD at (61 O) 397-2306.
SincereIv,
Director
Regulatory
Affairs
mhg
cc:
.-
Charles
Ganley,
Lilia Talarico,
-—
MD
MD
9C+W”0337
●
99GL092.DDC
7050
CAMP HILLROAD, FORT WASHINGTON, PA 19031-2299
(21>)
235-7700
absence
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KI
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$-
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TABLE OF CONTENTS
1.
Current
Labeling
2.
Requested
3.
Proposed
4.
Annotated
Exemptions
Labeling
Labeling
,,
-.
.—.
-
.. .
●
99GL092.DOC
*.
.
.—
.
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v
,.....
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.-
Repcid
-C.
Do not use if the individual blister unit is open or !om,
PEPCID AC Is Now Available in an Ensy-to-Swalfow G#lcHp
gslcap relleves heartburn due to acid Indigestion(Read Package Insert before use),
. PEPCID AC prwents heartiwm due m acid indigestion brought on by eating and
drinkingcertain foods and beverages.
.1
Drug Facts
Active ingredient (in each gelcap)
Purpost
Famotidine 10 mg ................... ..................................... ..................................... ......................................................Acld reduce
Uses
. relieves
heatiurn assocmed w“tfr acid indigestion and sour stomach
heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain
food and beverages
● prevents
Warninas
Afler!Jy al;;
Do not use if you are allergic to famotidine or otier acid reducers
Do not IISS
. if you have trouble swallowing
.%OII use and ask@ doctor if
● stomach
● with
other acid reducers
pain continues
● you
.
need to take this product for more than 14 days
‘Le
If prsgnant or brassf-feeding, ask a health professional before use.
Keep cmi of reach of childrsn. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
. aduhs and children 12 years and over:
. to Mime symptoms, swallow 1 gelcap with a glass of water
. to prsvent symptoms, swallow t gel cap with a glass of water at anytime from 15 to W minutes before
eating food or drinking beverages that cause heartburn
v
. do not use more than 2 oelca~ in 24 hours
● children under 12 years ask a-doctor
I
Facts (continued]
. read the direcdons
Dttfel ifdOflfA/WiOn
~AU~
and warnings before use
. keep the carton and package insert. Thay contain important information.
. protect from moisture
. stora at 25”- 3iYC (77” 86”F)
//faCtiVe ingradienk ben?yl alcohol, black iron oxide, butyfparaben, castor oil, edetate talcum disodium, FD&C
red #O, gelatin, hydro~ropyl methyfcellulose, magnesium stearater mathylparaben, microc~stalline cdlulose, pm- }
gelatinized com starch, propyfene gi.fcol,propylparaben, $oflum Iauryl suifate, sodium propionate, talc, titanium dioxide
.. .
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We are requesting
CFR Part
that
Due
201.
the pouch
to the
accommodate
the format
CFR
format
201.66
product
not
labeling.
sold
at the
establish
product
evaluate
a new
distributed
their
None
use
of
set forth
among
without
holding
and
have
in the final
falls
color
and
-.
including
no space
are requesting
99GL092.DOC
We
an opportunity
of
has
for Pepcid
not
been
deviation
are
indicate
made
6pt.
to
pouches
would
have
manda~ed
that
sure
that
AC Gelcaps.
minimum
However
size.
through
compromised.
from
for
this
to
6.5
the headings
The
the
We
requirements
listing
the
and
inactive
and
NDA
effective
required
use
ingredients.
of
the
We
are
requirement.
Packages
to reduce
pt.
from
safe
the
and
to
(d)(l O)(v) Hairlines
exemption
and barlines.
to
for Small
an allowance
7 pt.
subheadings
headings,
is critical
from
201 .66(d) (8) and 201.66
are requesting
required
Modifications
(Continued)”
from
from 7 pt. to 6 pt.
.
of minimal
is available
10)(ii)
separates
legibility
which
201 .66(d)(
of hairlines
to
to the size of the headings.
our goal
all of the
text
an exemption
We
are
industry
Millions
in the NDA
the agency’s
which
by the
provide
which
drug
ingredients
requesting
We
approved
(OTC)
21
rule.
approved
product,
to
money.
to
in the
vehicles
used
safety.
contrast
achieved
201 .66(c) (8) Inactive
After
and
of
of any evidence
below
been made
as sample
of 21
impossible
set forth
over-the-counter
solely
to public
as it was
content
have
for
provisions
it is virtually
requirements
consumers
threat
certain
are commonly
expenditure
any
is exactly
labeling
we
pouches
from
package
content
are intended
and we are unaware
content
that
of the
of the
Such
has posed
be exempt
requirements
pouches
awareness
adjustments
believe
size
content
level.
product
annually
of the
Certain
the
These
distribution
the textual
small
and some
and
retail
package
the
size
reduce
of the
the
title
size
“Drug
of the
Facts
headings
and Barlines
requirement
use of holding
and subheadings.
the
which
and color
mandates
contrast
the
use
sufficiently
.
.=
-.
‘ --
g Facts (c0ntmu&3- .*tmchp=Jig#
‘~;<+,
you wed to take tits pmduc! for more than 14 days
O*J
+
PIw bMMI-~~i
aska kaahhPfokss(cnalbefore use
*@ ~
q w of msck of childmm In case of overdose, gel medical
Ip w contact a Pomon Comrol Center right away,
LVroetiorn. addts and chddrm 12yews ad over
$
, [o relieve symp!ans, s.vallnw I gekap ‘Mh a gkss of water
-to prevert sqmptnms,swalu.v 1 gelcap wnh a ~ass of watnr al
BrV t!mc Imm 15to 69 mimes belcw eatwg hod M drinking
bwerages that causs heantmun . do not use mwe than 2
I
ekaps in 24 hours . chtidrenundel 12years ask a doctor
Other inlornmtion. read the dkectmnsandwammgs befcm use
. stow beiwem 25.20C 177.P6FI . prow! ffom mmtiwe
pitt. * @AlU8n+ahM!
. WS?x cHIJmAauncus co.
JMTWMHMGTLW. rh IWM USA aIR*a.ti~d~ti
dmiti L
-1CO,h.
~ddabdw”
Drug
Facts
Active ingrnciem fin each gelcap)
PUQDS
Famotidme 10 reg .............. ,......... . ... . .. .............. . .. ... . .........Ac!d red,,e
{
Uses . celteves heartburn associated w,th sc!d lnd!gesnon a“d sour
Nomach
. prevents heartburn assoc!a!ed with actd ,ndg Won and sw
momach brough! on by eatuig or dr!nkng certain food and%1everages
l%,”;”..
$lb~ akm do not use II you are allerglc to Iamotzdme O( orher acid reducers
Do not usc .jfywhv~~~uble
wdlowmg.
. WLnti~a~&educers
4
4“
-—
-1-m.
uo noI useu pottcnIs Open
or torn.
I
–...
,.
–-–.
Y
1
Ge/cap
(Gelatin
Camu/e
hug
“’
~
Coafed,
Sha~ed Tab/efj
Facts
(in each gelcap)
Purpos~
Famotidine 10 mg .........................................................................Acid reduceri
Uses . relieves heartburn associated with acid indigestion and sour
● prevents
hea~burn associated with acid indlgesbon and souq
stomach
stomach brought on by eating or drinking certain food and beverages
Warnings
Allergy alert do not use if you are allergic to famot!dme or other acid reducers
Do n.ot.use .“!f you have trouble. swallowin~ ..:wlth other acid redu.ce.rs
--d
J4ctive ingredient
150!40
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3
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(OTC) GELCAP POUCH-CR
Drug Facts
7.5 pt. Univers 65 Bold Oblique (94% horiz. scale)
Uses (subheads)
6 pt. Univers 67 Condensed
Bold Oblique (94% horiz. scale)
relieves (text)
6 pt. Univers 57 Condensed
(90?4 horiz. scale)
[bullets)
5 pt. Univers 57 Condensed
(90?4 horiz. scale)
Do not (text)
6 pt. Univers 67 Condensed
Bold (85% horiz. scale)
●
Drug
Facts
(continued)
(cd)
6.5 pt. Univers 65 Bold Oblique (85?4 horiz. scale)
6.5 pt. Univers 55 (85Y0 horiz. scale)
I
I
,4
contmuecf)
/
m d da
dadwif .stcmuch tin ccmnnues
you need to take his prohct fol me than 14 dqs
pf@w~a*ahe*
In case of ,~rdose, get medical
w contact a Pcdsm Cmtrol Center right awav.
lmXfons
. adtis ad Ch*Eil fl yeal? ad w
maliw 1 gekap~
a glm afwater
In Awe sfmmts,
to prewm qlnfltorll% *aRmw 1 geicap,wllh a *SS OfVmtw at
w nme kom 1$.toSl nurwtesbefc+e eating food w tinking
WWaW$ III* cause hew$wm
. do R+I use rnwe than 2
dcaps m 24 lmurs . chddrenundu 12years ask a doctor
(lthwinlornmfion.
readtie diwmu andwamrngs befwe we
Sore bewwen 5-KC (7746FI . prrt~t frwn momture
d.tq&b+&u.&fllcX-FwHwmwo.
lW$~T~,
PAI!W ~ m H titillkdw.g
pmtmfraacb
dohiidrm
Headings
r
Drug Facts (Continued]
@
c%
11 i
Reduced
from
7 pt.
to 6 pt.
Reduced
0
~AC
1Ge/cap
rug~acts lcontmuecf)
‘
!
Purpos
ctive ingredient (in each gelcapl
Famotidine 10 mg .........................................................................Acid reduce {
sas ● relieves heartburn associated with acid indigestion and sour
. prevents heartburn associated with acid indigestion and sou
~omach
!
stomach brought on by eating or drinking certain food and beverages
~ffmiffg$-
do not use if you are allergic to famotidine or otier acid reducers
with other acid reducers WI
If guhaxe trouble swallowing
o
$- L-.--2
Hergy alert
not use ●
6.5
pt.
x 0000000 ~
‘&\
‘$’~
&
+
/Q\
@& \
‘+
02 \
you need to take this product for more tian 14day’s
&# 44
pregnant
or braesMeding, ask a health professional before use
84> $’
ap out ofreach of children. In case of overdosa, get medical
elp or contact a Poison Control Center right away.
irectkms ● aduits and childran 12years and ovec
$
to relieva symptoms,swallow 1 geicap with a glass of water
to prevent symptoms, swallow 1 gelcap with a glass of water at
nytime fram 15to 60 minutes before eating food or drinking
evarages that cause heartburn ● do not use more than 2
elcaps in 24hours ● children under 12years ask a doctor
er inbnetion ● raad the duections and warnings before use
store between 25-30C(77-86F] . protect from moisture
WNSUMER
PHARMACEUTICALS
CO.
ht. by @fWWGW-.
~
01Mardr&Co.,Inc.
RT WASH fNliTOS, PA190S4 USA @ RqAstwMItradamark
rug Facts
~ ~
to
taptraeand ask a doctor if ● stomach pain ~ontmues ‘
(Gelatin Coated,
Capsule Shaped Tablet)
Famotidine Table[s 10mg/@
Acid Reducer
7 pt.
w
Pepciir ‘-:==~~
4
frogm
●
Hairfinas and Barlines
1
Inactive Ingredients
Not
Not
Used
150!40
Listed
%
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