[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11790-11793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4702]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-1981-N-0077 (formerly 81N-0393), FDA-1981-N-0248
(formerly 81N-0396), FDA-1982-N-0046 (formerly 82N-0095), FDA-1982-N-
0264 (formerly 82N-0096), and FDA-1983-N-0137 (formerly 83N-0095); DESI
6514, 11935, and 12152]
Drugs for Human Use; Drug Efficacy Study Implementation; Oral
Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or
Allergy; Withdrawal of Hearing Requests; Final Resolution of Dockets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that all
outstanding hearing requests pertaining to oral prescription drugs
offered for relief of symptoms of cough, cold, or allergy, Docket Nos.
FDA-1981-N-0077 (formerly 81N-0393), FDA-1981-N-0248 (formerly 81N-
0396), FDA-1982-N-0046 (formerly 82N-0095), FDA-1982-N-0264 (formerly
82N-0096), and FDA-1983-N-0137 (formerly 83N-0095), have been
withdrawn. Therefore, shipment in interstate commerce of the products
identified in those dockets, or any identical, related, or similar
(IRS) product that is not the subject of an approved new drug
application (NDA) or abbreviated new drug application (ANDA) (other
than an over-the-counter (OTC) product that complies with an
[[Page 11791]]
applicable OTC monograph), is unlawful as of the effective date of this
notice.
DATES: Effective Date: This notice is effective March 3, 2011.
ADDRESSES: All communications in response to this notice should be
identified with the appropriate docket number, and directed to Sakineh
Walther, Division of New Drugs and Labeling Compliance, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 51, rm. 5242, Silver Spring, MD 20993-0002.
FOR FURTHER INFORMATION CONTACT: Sakineh Walther, Division of New Drugs
and Labeling Compliance, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5242,
Silver Spring, MD 20993-0002, 301-796-3349, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of January 7, 2011
(76 FR 1174) (the January 7, 2011, notice), FDA announced that all
outstanding hearing requests pertaining to certain dockets established
under the Agency's Drug Efficacy Study Implementation (DESI) program
had been withdrawn.1 2 Also in that notice, FDA announced
the withdrawal of certain hearing requests pertaining to Docket Nos.
FDA-1981-N-0077 (formerly 81N-0393), FDA-1981-N-0248 (formerly 81N-
0396), FDA-1982-N-0046 (formerly 82N-0095), FDA-1982-N-0264 (formerly
82N-0096), and FDA-1983-N-0137 (formerly 83N-0095), and offered an
opportunity for companies with outstanding hearing requests under those
dockets to withdraw or affirm their outstanding hearing requests.
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\1\ For background on the DESI review in general and the DESI
review as it relates to the dockets addressed in this notice, please
see the January 7, 2011, notice.
\2\ In the January 7, 2011, notice, FDA stated that with respect
to Docket No. FDA-1982-N-0225 (formerly 82N-0078), Chlor-Trimeton
Repetabs Tablets, containing 12 milligrams (mg) chlorpheniramine
maleate and marketed under NDA 7-638, had been discontinued. FDA
notes that NDA 7-638 is currently active; however, products under it
are not marketed for indications found ineffective under DESI.
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A. Docket No. FDA-1981-N-0077 (formerly 81N-0393) (DESI 6514)
The products reviewed under Docket No. FDA-1981-N-0077 (formerly
81N-0393) (DESI 6514) were Phenergan Expectorant with Codeine
(containing promethazine hydrochloride, ipecac fluidextract, potassium
guaiacolsulfonate, citric acid, sodium citrate, and codeine phosphate,
marketed under NDA 8-306); Phenergan VC Expectorant Plain (containing
promethazine hydrochloride, ipecac fluidextract, potassium
guaiacolsulfonate, citric acid, sodium citrate, and phenylephrine
hydrochloride, marketed under NDA 8-306); Phenergan VC Expectorant With
Codeine (containing promethazine hydrochloride, ipecac fluidextract,
potassium guaiacolsulfonate, citric acid, sodium citrate, phenylephrine
hydrochloride, and codeine phosphate, marketed under NDA 8-306);
Phenergan Expectorant Plain (containing promethazine hydrochloride,
ipecac fluidextract, potassium guaiacolsulfonate, citric acid, and
sodium citrate, marketed under NDA 8-604); and Pediatric Phenergan
Expectorant with Dextromethorphan (containing promethazine
hydrochloride, ipecac fluidextract, potassium guaiacolsulfonate, citric
acid, sodium citrate, and dextromethorphan hydrobromide, marketed under
NDA 11-265). In a notice published in the Federal Register of May 25,
1982 (47 FR 22610), FDA revoked the temporary exemption that permitted
these drug products, and those products IRS to these products, to
remain on the market beyond the time limit established for DESI. The
notice also reclassified the products to lacking substantial evidence
of effectiveness, and offered an opportunity for a hearing on a
proposal to withdraw approval of the NDAs for the products.
After Wyeth Laboratories, the holder of the NDAs for the Phenergan
products, withdrew its hearing request after approval of reformulated
versions of four of its five products, FDA announced in the Federal
Register of August 15, 1984 (49 FR 32681) that the Agency was
withdrawing approval of NDAs 8-306, 8-604, and 11-265 pertaining to the
old formulations of the Phenergan products, effective September 14,
1984.
At the time of the January 7, 2011, notice (76 FR 1174), there were
two outstanding hearing requests under this docket filed by Bay
Laboratories, 3654 West Jarvis, Skokie, IL 60076, for its IRS products
Promethazine Expectorant with Codeine, Promethazine VC Expectorant
Plain, Promethazine VC Expectorant with Codeine, Promethazine
Expectorant Plain, and Promethazine Pediatric Expectorant, and by
National Pharmaceuticals, Inc., 7205 Windsor Blvd., Baltimore, MD
21207, for its products IRS to all five Phenergan products considered
under this docket. FDA was unable to find current contact information
for Bay Laboratories and National Pharmaceuticals. In the January 7,
2011, notice, FDA gave these companies an opportunity to affirm or
withdraw their hearing requests. Requests that were not affirmed within
30 days of that notice were to be deemed withdrawn by FDA.
B. Docket FDA-1981-N-0248 (formerly 81N-0396) (DESI 6514)
The products reviewed under Docket No. FDA-1981-N-0248 (formerly
81N-0396) (DESI 6514) were Dimetane Expectorant (containing
brompheniramine maleate, phenylephrine hydrochloride,
phenylpropanolamine hydrochloride, and guaifenesin, marketed under NDA
11-694); Dimetane Expectorant-DC (containing codeine phosphate,
brompheniramine maleate, phenylephrine hydrochloride,
phenylpropanolamine hydrochloride, and guaifenesin, marketed under NDA
11-694); and Actifed-C Expectorant (containing codeine phosphate,
triprolidine hydrochloride, pseudoephedrine hydrochloride, and
guaifenesin, marketed under NDA 12-575). In a notice published in the
Federal Register of May 25, 1982, FDA revoked the temporary exemption
that permitted these drug products, and those products IRS to these
products, to remain on the market beyond the time limit established for
DESI. The notice also reclassified the products to lacking substantial
evidence of effectiveness, and offered an opportunity for a hearing on
a proposal to withdraw approval of the NDAs for the products.
On April 3, 1984, A.H. Robins, the holder of the NDA for Dimetane
Expectorant and Dimetane Expectorant-DC, withdrew its hearing request
after approval of reformulated versions of its products. Accordingly,
in the Federal Register of August 24, 1984 (49 FR 33726), FDA announced
that it was withdrawing approval of those portions of NDA 11-694
pertaining to the old formulations of the Dimetane Expectorant
products, effective September 24, 1984.
In the Federal Register of September 14, 1984 (49 FR 36169), FDA
announced that it was withdrawing approval of those portions of NDA 12-
575 pertaining to the old formulation of Actifed-C Expectorant,
effective October 15, 1984, after the NDA holder, Burroughs Wellcome,
obtained approval for a reformulated version of the product and
withdrew its hearing request.
At the time of the January 7, 2011, notice, there were two
outstanding
[[Page 11792]]
hearing requests under this docket filed by Bay Laboratories, 3654 West
Jarvis, Skokie, IL 60076, for its IRS products Triphen Expectorant,
Triphen Expectorant DC, and Pseudodine ``C'' Expectorant, and by
National Pharmaceuticals, Inc., 7205 Windsor Blvd., Baltimore, MD
21207, for its products IRS to Dimetane Expectorant, Dimetane
Expectorant DC, and Actifed-C. FDA was unable to find current contact
information for Bay Laboratories and National Pharmaceuticals. In the
January 7, 2011, notice, FDA gave these companies an opportunity to
affirm or withdraw their hearing requests. Requests that were not
affirmed within 30 days of that notice were to be deemed withdrawn by
FDA.
C. Docket FDA-1982-N-0046 (formerly 82N-0095) (DESI 6514, 11935)
The products reviewed under Docket No. FDA-1982-N-0046 (formerly
82N-0095) (DESI 6514 and 11935) were Ambenyl Expectorant (containing
codeine sulfate, bromodiphenhydramine hydrochloride, diphenhydramine
hydrochloride, ammonium chloride, potassium guaiacolsulfonate, and
menthol, marketed under NDA 9-319); and Pyribenzamine and Ephedrine
Tablets (containing tripelennamine hydrochloride and 12 mg ephedrine
sulfate, marketed under NDA 5-914). In a notice published in the
Federal Register of May 25, 1982 (47 FR 22604), FDA revoked the
temporary exemption that permitted these drug products, and those
products IRS to these products, to remain on the market beyond the time
limit established for DESI. The notice also reclassified the products
to lacking substantial evidence of effectiveness, and offered an
opportunity for a hearing on a proposal to withdraw approval of the
NDAs for the products.
In the Federal Register of May 24, 1983 (48 FR 23311), FDA
announced that it was withdrawing approval of NDA 5-914 as it pertains
to Pyribenzamine and Ephedrine Tablets, effective June 23, 1983,
because no hearing was requested for the product by the NDA holder. On
February 27, 1984, Marion Laboratories, the NDA holder for Ambenyl
Expectorant, withdrew its hearing request after a reformulated version
of its product was approved. Accordingly, in the Federal Register of
August 24, 1984, FDA announced it was withdrawing approval of those
portions of NDA 9-319 pertaining to the old formulation of Ambenyl
Expectorant, effective September 24, 1984.
At the time of the January 7, 2011, notice, there was one
outstanding hearing request under this docket filed by National
Pharmaceuticals, Inc., 7205 Windsor Blvd., Baltimore, MD 21207, for its
products IRS to Ambenyl Expectorant. FDA was unable to find current
contact information for National Pharmaceuticals. In the January 7,
2011, notice, FDA gave this company an opportunity to affirm or
withdraw its hearing request. Its hearing request was to be deemed
withdrawn if the company did not affirm the request within 30 days of
that notice.
D. Docket FDA-1982-N-0264 (formerly 82N-0096) (DESI 12152)
The product reviewed under Docket No. FDA-1982-N-0264 (formerly
82N-0096) (DESI 12152) was Ornade Spansules. Ornade Spansules, as
formulated early in the DESI review process, was a three-ingredient
product containing 8 mg of chlorpheniramine maleate, 50 mg of
phenylpropanolamine hydrochloride, and 2.5 mg of isopropamide, and was
marketed under NDA 12-152. Subsequently, Ornade Spansules was
reformulated as a controlled-release product containing 12 mg
chlorpheniramine maleate and 75 mg phenylpropanolamine. In a notice
published in the Federal Register of August 17, 1982 (47 FR 35870), FDA
revoked the temporary exemption that permitted Ornade Spansules, as
originally formulated, and those products IRS to it, to remain on the
market beyond the time limit established for DESI. In the notice, FDA
also announced the conditions for marketing Ornade Spansules, as
reformulated, and the products IRS to it, for the indication for which
they were regarded as effective, and offered an opportunity for a
hearing concerning a proposal to withdraw approval of the NDA with
respect to the old formulation and the indications reclassified to
lacking substantial evidence of effectiveness.
In the Federal Register of December 12, 1984 (49 FR 48387), FDA
announced that it was withdrawing approval of those portions of NDA 12-
152 covering the old, three-ingredient formulation for Ornade
Spansules, effective January 11, 1985, noting that no party submitted a
hearing request regarding the three-ingredient formulation.
At the time of the January 7, 2011, notice, there were two
outstanding hearing requests under this docket filed by Pioneer
Pharmaceuticals, Inc., 209 40th Street, Irvington, NJ 07111, for its
IRS product characterized by the company as a generic version of Ornade
Spansules, and by Zenith Laboratories, Inc., 140 LeGrand Ave.,
Northvale, NJ 07647, for its IRS product, a sustained release product
containing chlorpheniramine and phenylpropanolamine. FDA did not
receive any response to its attempt to contact Zenith Laboratories and
was unable to find current contact information for Pioneer
Pharmaceuticals, Inc. In the January 7, 2011, notice, FDA gave these
companies an opportunity to affirm or withdraw their hearing requests.
Requests that were not affirmed within 30 days of that notice were to
be deemed withdrawn by FDA.
E. Docket FDA-1983-N-0137 (formerly 83N-0095) (DESI 11935)
The products reviewed under Docket No. FDA-1983-N-0137 (formerly
83N-0095) (DESI 11935) were Dimetapp Extentabs and Dimetapp Elixir. As
originally formulated during the period of the DESI review, Dimetapp
Extentabs contained 12 mg brompheniramine maleate, 15 mg phenylephrine
hydrochloride, and 15 mg phenylpropanolamine hydrochloride in
controlled-release form, and was marketed under NDA 12-436; and
Dimetapp Elixir contained 4 mg brompheniramine maleate, 5 mg
phenylephrine hydrochloride, and 5 mg phenylpropanolamine hydrochloride
per 5 milliliters (mL), and was marketed under NDA 13-087. In a notice
published in the Federal Register of December 23, 1983 (48 FR 56854)
(the December 23, 1983, notice), FDA revoked the temporary exemption
that permitted these drug products, and those products IRS to these
products, to remain on the market beyond the time limit established for
DESI, and offered an opportunity for a hearing concerning a proposal to
withdraw approval of the NDAs for the original formulations of these
products and for the indications reclassified to lacking substantial
evidence of effectiveness.
At the time of the publication of the December 23, 1983, notice,
the manufacturer had submitted supplemental applications proposing to
reformulate Dimetapp Extentabs to contain 12 mg brompheniramine maleate
and 75 mg phenylpropanolamine hydrochloride in a controlled-release
form, and Dimetapp Elixir to contain 4 mg brompheniramine maleate and
25 mg phenylpropanolamine hydrochloride per 5 mL. The supplements to
NDA 12-436 and NDA 13-087 were approved by FDA on April 20, 1984, and
March 29, 1984, respectively. In the December 23, 1983, notice, FDA
also announced the conditions for marketing the reformulated versions
of these products
[[Page 11793]]
for the indication for which they were regarded as effective.
At the time of the January 7, 2011, notice (76 FR 1174), there were
14 outstanding hearing requests under this docket filed by American
Therapeutics Inc., 75 Carlough Rd., Bohemia, NY 11716, for its product
IRS to Dimetapp Extentab Tablets; Amide Pharmaceutical, Inc., 101 East
Main St., Little Falls, NJ 07424, for its IRS product Ami-Tapp; Bay
Laboratories, Inc., 3654 West Jarvis, Skokie, IL 60076, for Triphen
Elixir, its product IRS to Dimetapp Elixir; Carnrick Laboratories,
Inc., 65 Horse Hill Rd., Cedar Knolls, NJ 07927, for Nolamine Timed
Release Tablets, its product IRS to Dimetapp Extentabs; Copley
Pharmaceutical, Inc., 398 West Second St., P.O. Box 107, Boston, MA
02127, for its products IRS to Dimetapp Extentabs; LuChem
Pharmaceuticals, Inc., P.O. Box 6038, 8910 Linwood Ave., Shreveport, LA
71136, for its IRS products Ban-Tuss HC, Ban-Tuss C Expectorant, Tuss-
Delay Tablets, Ban-Tuss Plain, Klerist-D Tablets, Respergen, Am-Tuss
Liquid, Novadyne DH, Novadyne Expectorant, Dexophed Tablets, Chem-Tuss-
SR, Chem-Tuss Elixir, Chem-Tuss DM, Chem-Tuss DME, and Chem-Tuss N;
Mayrand Inc., 4 Dundas Circle, P.O. Box 8860, Greensboro, NC 27419, for
its products IRS to Dimetapp Extentabs and Dimetapp Elixir; National
Pharmaceutical Manufacturing Co., 7205 Windsor Blvd., Baltimore, MD
21207, for its product IRS to Dimetapp Elixir; Pharmaceutical Basics,
Inc., 301 S. Cherokee, Denver, CO 80223, for its IRS product Basamine
S.R. Tablets; Pioneer Pharmaceuticals, Inc., 209 40th St., Irvington,
NJ 07111, for Pioten Tablets, its product IRS to Dimetapp Extentabs;
Quantum Pharmics, Ltd., 26 Edison St., Amityville, NY 11701, for its
IRS product, Brom-Tapp; Superpharm Corp., 155 Oval Dr., Central Islip,
NY 11722, for its product IRS to Dimetapp Extentab Tablets; United
States Trading Corp., 10718 McCune Ave., Los Angeles, CA 90034, for its
products IRS to Dimetapp Extentabs; and Upsher-Smith Laboratories,
Inc., 14905 23d Ave. North, Minneapolis, MN 55441, for unspecified
products.
FDA was unable to find current contact information for American
Therapeutics, Amide Pharmaceutical, Inc., Bay Laboratories, Inc.,
National Pharmaceutical Manufacturing Co., Pharmaceutical Basics, Inc.,
Superpharm Corp., and United States Trading Corp. FDA did not receive
any response to its attempt to contact Carnrick Laboratories, a
subsidiary of Elan Corp., PLC, 800 Gateway Blvd., South San Francisco,
CA 94080; Copley Pharmaceutical, Inc.; LuChem Pharmaceuticals, Inc.;
Merz Pharmaceuticals, LLC, P.O. Box 18806, Greensboro, NC 27419,
successor to Mayrand Inc. Pharmaceuticals; Pioneer Pharmaceuticals,
Inc.; Quantum Pharmics, Ltd.; or Upsher-Smith Laboratories, Inc. In the
January 7, 2011, notice, FDA gave these companies an opportunity to
affirm or withdraw their hearing requests. Requests that were not
affirmed within 30 days of that notice were to be deemed withdrawn by
FDA.
II. Final Resolution of Docket Nos. FDA-1981-N-0077 (formerly 81N-
0393), FDA-1981-N-0248 (formerly 81N-0396), FDA-1982-N-0046 (formerly
82N-0095), FDA-1982-N-264 (formerly 82N-0096), and FDA-1983-N-0137
(formerly 83N-0095)
The time period for responding to the January 7, 2011, notice has
elapsed, and no companies with outstanding hearing requests responded
to the notice. Because no outstanding hearing requests were affirmed in
response to the January 7, 2011, notice (or in response to FDA's
previous attempts to contact companies with outstanding hearing
requests), all of the outstanding hearing requests pertaining to Docket
Nos. FDA-1981-N-0077 (formerly 81N-0393), FDA-1981-N-0248 (formerly
81N-0396), FDA-1982-N-0046 (formerly 82N-0095), FDA-1982-N-0264
(formerly 82N-0096), and FDA-1983-N-0137 (formerly 83N-0095) are deemed
to be withdrawn. Therefore, shipment in interstate commerce of the
products identified in those dockets, or any IRS product that is not
the subject of an approved NDA or ANDA, is unlawful as of the effective
date of this notice. This notice is not applicable to OTC products that
comply with an OTC monograph (21 CFR 310.6(f)). Any person who wishes
to determine whether a specific product is covered by this notice
should write to the Center for Drug Evaluation and Research (see
ADDRESSES).
III. Discontinued Products
Some firms may have previously discontinued the manufacturing or
distribution of products covered by this notice without removing them
from the listing of their products under section 510(j) of the Federal
Food, Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(j)). Other
firms may discontinue manufacturing or marketing listed products in
response to this notice. Firms that wish to notify the Agency of
product discontinuation should send a letter, signed by the firm's
chief executive officer, fully identifying the discontinued product(s),
including NDC number(s), and stating that the product(s) has (have)
been discontinued. The letter should be sent to Sakineh Walther (see
ADDRESSES).
Firms should also update the listing of their products under
section 510(j) of the FD&C Act to reflect discontinuation of unapproved
products. FDA plans to rely on its existing records, including drug
listing records or other available information, when it targets
violations for enforcement action. Firms should be aware that, after
the effective date of this notice, FDA intends to take enforcement
action without further notice against any firm that manufactures or
ships in interstate commerce any unapproved product covered by this
notice that is not the subject of an ongoing DESI proceeding.
IV. Reformulated Products
Some of the active ingredients found in drug products covered by
this notice are included in the OTC monograph in 21 CFR part 341,
``Cold, Cough, Allergy, Bronchodilator, and Antihistamine Drug Products
for Over-the-Counter Human Use.'' OTC products that comply with the
monograph may be marketed without approval.
However, FDA cautions firms against reformulating products into OTC
products or different unapproved new drugs that are marketed under the
same name or substantially the same name (including a new name that
contains the old name). Reformulated products marketed under a name
previously identified with a different active ingredient or combination
of active ingredients have the potential to confuse health care
practitioners and harm patients.
This notice is issued under sections 502 and 505 of the FD&C Act
(21 U.S.C. 352 and 355), and under authority delegated to the Assistant
Commissioner for Policy under section 1410.21 of the FDA Staff Manual
Guide.
Dated: February 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4702 Filed 3-2-11; 8:45 am]
BILLING CODE 4160-01-P