Download DEPARTMENT OF HEALTH AND HWAN SE&VICES

DEPARTMENT OF HEALTH AND HWAN SE&VICES
FOOD AND DRUG ADLL~INISTRATION
[DOCKET NO. 76N-0052]
COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC
DRUG PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
DECISION
c-y
AGENCY:
Food
ACT ION :
Notice.
ON DOSAGE OF PSEUDOEPHEDRINE PREPARATIONS
and Drug
SUMIVIARY: The Fooil
until
orai
furtner
nasai
an6 Drug
notice
the
aecongestant
pseuaoepnedrine
are
dosage
Interval.
dosage
interval
from
every
6 nours
three
manufacturers
every
aata
4 to
reflecting
dosage
of
Antiasthmatic
date
uelng
stayed
pseudoepnedrine
OTC Coid,
Drug
1981,
changing
to
reduce
preparations
in
will
OTC
revised
the
4 hours
Aiiergy,
interval
the
the
50 mg
froti
-
and
shouici
be
laDeling
maximum daiiy
proposed
2roncnodllator,
nor. be stayed
hourly
to
a petition
revised
to
Cougn,
Proaucts
date
aosage
requirea
aecision
FDA's
new pharmacokinetic
nourly
However,
extending
of
witll
response
who submitted
is
manufacturers
(my) every
in
the
(FDA)
containing
to comply
60 miillgrams
agency's
May i,
products
The effective
6 hours.
for
oy wnich
drug
to show that
the
monograpn
effective
is
Administration
required
hourly
safety
Administration.
and will
and
aecome
DATE:
Tne effective
inaximum aaily
required
untli
date
uosage
requirea
relaoeling
198i.
The effective
is Nay 1,
relabeling
further
ior
for
notice,
tne
hourly
pending
dosage
review
of
for
tne
date
interval
is
for
stayed
new data,
FOR FURTHER INFORMATION CONTACT:
\i\lilli.am
E. Gilbertson,
Bureau
Food
of
Drugs
and Drug
(HFD-SiO),
Administration
5600 Fishers
I
Lane,
Rockville,
MD
20857,
301-443-4560.
SUPPLBMENTARY INFO.WATION:
September
that
the
aaily
30,
1980
availaole
dosage
drug
OTC use as an oral
oy the
Aavrsory
explained
tnat
products
nasal
data
of
significant
side
and that
appropriate.
not
tne
support
Panel
Panel's
effects
a 240-mg
the
containing
decongestant
that
the
proposed
could
360-mg
Cough,
concluded
from
that,
for
recommendea
Allergy,
after
monograpn
maximum dally
maximum
The notice
agency
result
decision
had been
Proaucts.
to
tne
pseudoepnedrine
on OTC Cold,
suomitted
The agency
FEDERAL REGISTER of
FDA announced
and Antiasthmatic
pubiication
dosage
uid
Review
Bronchodilator,
the
(45 FR 64709),
data
for
In
the
dosage
under
the
suggest
360-mg
that
daily
LS more
tne
procedures
-
established
labeied
in
with
-
21 CFR 330.13(b)(2),
the
be relabeled
3
nigner
witn
dosage
specified
pseudoephedrine
limitations
lower
products
would
dosage
be required
limitations
to
by January
isal.
30,
In
the
the
FEDERAL REGiST5R of
agency
granted
the
1381,
two petitions
effective
limitatsons
December
date
that
for
had oeen
19,
1980
and extended
compliance
set
forth
until
with
in
the
(45 r"R 8367l.),
the
May 1,
revised
September
dosage
30,
1980
notice.
On Aprii
Corp.,
2,
the
60-mg
petitioners
every
Hay 1,
pharmacokinetlc
instead
requested
they
suomitted
for
decision.
was provided
(A copy
(formeriy
Fooa and Drug
MD
of
20857.
and a
tnem
to
petition
the
Administration,
of
weie
issued,
products
the
of
as the
to enable
pseudoephedrine
LPIanagement Branch
Rockville,
thereto
The
an extension
which
respect
which
interval
data
labeiing
Lane,
a dosage
and safety
revise
Fishers
of
Co.
6 hours.
time
thereafter
(%?A-30ti),
to every
The petitioners
with
Schering
tine decision
such
time
office)
of
until
reasonaole
Dockets
part
date
a decision
final
from
effective
evaluatea,
the
that
interval
adoption
6 hours.
198i,
a petition
and Burroughs-Wellcome
of
dosage
sought
4 to
agency's
Co.,
reconsideration
extends
tne
FDA received
The Dow Cnemical
requesting
the
1981,
is
Rearing
to
reflect
on file
the
in
Clerk's
-Rm. 4-62,
5600
- 4 The petitioners
based
new pharmacokinetic
aione
and in
malor
determinant
pH of
tne
dosing
more
combination
of
belleve
rsflectrve
dosage
of
every
data
with
the
every
of
the
other
drugs,
of
the
data
4 to
6 hours
have
is
that
6 hours
is
blood
established
both
shown
that
the
The
that
a flexible
permissible
and is
levels
in
the
is
excreted.
demonstrate
achievaDle
belief
pseudoephedrine
pseudoephedrine
that
of
on their
on pseudoephedrine,
naif-life
in whicn
schedule
request
and safety
urine
petltloners
their
the
than
the
September
fixed
30,
1930
notice.
FDA nas considered
good
and sufficient
until
further
the
revised
the
new data
products
notlce
are
labeled
6 hours
until
the
of
reason
the
dosage
every
agency's
a 24-hour
in
the
excess
of
1931
60 mg every
In
the
also
period
from
30,
240 mg of
state
reauce
360 to
staying
6 hours
for
until
pseudoephedrine
4 hours
or
60 mg
OTC drug
on the
that
date
interim,
on the
aosage
for
effective
of
a decision
6- nour
to
provided
60 mg every
issues
decision
September
May i,
De permitted
Tne petitioners
and has conciudeb
has been
reviewed.
will
4- to
request
interval
eitner
agency
an every
this
market
appropriateness
interval.
that
the
pseudoephedrine
support
maximum aduit
240 mg.
1930 notlce
they
that
the,
dosage
The agency
a daily
auring
deelded
dosage
may i3e associated
in
-with
L
significant
side
Therefore,
benefit.
reflecting
labeling
aaults
will
forth
effects
for
tie
and corresponding
not
in
be stayea
the
without
safety
Septem ber
reasons,
m axim um daily
m axim um dally
and will
therapeutic
additional
requirea
OTC dosage
of
OTC aosages
becom e effective
30 and Decem ber
revised
L9,
M ay I,
1980
240 m g for
for
children
1981
notices,
as set