Phenylpropanolamine; Withdrawal of Approval of 13 New Drug Applications and 7 Abbreviated New Drug Applications, 9744-9745 [2014-03596]

Download as PDF 9744 Federal Register / Vol. 79, No. 34 / Thursday, February 20, 2014 / Notices products are no longer considered safe due to the association of phenylpropanolamine use with increased risk of hemorrhagic stroke. The holders of these NDAs and ANDAs have waived their opportunity for a hearing. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2001–N–0274 (formerly 01N–0196)] Phenylpropanolamine; Withdrawal of Approval of 13 New Drug Applications and 7 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing approval of 13 new drug applications (NDAs) and 7 abbreviated new drug applications (ANDAs) for products containing phenylpropanolamine. The basis for the withdrawals is that the SUMMARY: DATES: Effective February 20, 2014. FOR FURTHER INFORMATION CONTACT: Emily Helms Williams, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993–0002, 301– 796–3381. SUPPLEMENTARY INFORMATION: On November 3, 2000, the Director of FDA’s Center for Drug Evaluation and Research (the Director) sent a letter to holders of NDAs and ANDAs for drug products containing phenylpropanolamine requesting that they voluntarily discontinue marketing any such products due to developments indicating an association between phenylpropanolamine use and increased risk of hemorrhagic stroke. Subsequently, in a notice published in the Federal Register on August 14, 2001 (66 FR 42665), the Director offered an opportunity for a hearing on a proposal to issue an order, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and 21 CFR 314.150(a)(2), withdrawing approval of 13 NDAs and 8 ANDAs for products containing phenylpropanolamine. (Although the August 14, 2001, notice stated that FDA proposed to withdraw approval of 16 NDAs and 8 ANDAs, the notice listed only 13 NDAs and 8 ANDAs.) The following products, all of which have been discontinued, were listed in the notice: TABLE 1—NDAS AND ANDAS FOR WHICH FDA HAS PROPOSED TO WITHDRAW APPROVAL OF THE APPLICATIONS Application No. Drug Applicant NDA 11–694 ...... NDA 12–152 ...... Dimetane-DC Syrup ............................................. Ornade Extended-Release Tablet ........................ NDA 12–436 ...... NDA 13–087 ...... NDA 18–050 ...... Dimetapp Extended-Release Tablet .................... Dimetapp Elixir ..................................................... Corsym Extended-Release Suspension .............. NDA 18–099 ...... Contac Extended-Release Capsule ..................... NDA 18–298 ...... NDA 18–556 ...... Tavist-D Extended-Release Tablet ...................... Demazin Extended-Release Tablet ..................... NDA 18–809 ...... Phenylpropanolamine Hydrochloride (HCl) Chlorpheniramine Maleate Extended-Release Capsule. Hycomine Syrup ................................................... Hycomine Pediatric Syrup .................................... Contac Extended-Release Tablet ........................ Tavist-D Extended-Release Tablet ...................... Bromatapp Extended-Release Tablet .................. A.H. Robins Co., P.O. Box 8299, Philadelphia, PA 19101. SmithKline-Beecham, 1250 South Collegeville Rd., P.O. Box 5089, Collegeville, PA 19426. Whitehall-Robins, 5 Giralda Farms, Madison, NJ 07940. Do. Medeva Americas, Inc., 755 Jefferson Rd., P.O. Box 1710, Rochester, NY 14603. SmithKline Beecham Consumer Health, L.P., 1500 Littleton Rd., Parsippany, NJ 07054. Novartis Consumer Health, Inc., 560 Morris Ave., Summit, NJ 07901. Schering-Plough HealthCare Products, Three Oak Way, P.O. Box 603, Berkeley Heights, NJ 07922. Schwarz Pharma, 6140 West Executive Dr., Mequon, WI 53092. NDA 19–410 ...... NDA 19–411 ...... NDA 19–613 ...... NDA 20–640 ...... ANDA 71–099 .... ANDA 88–687 .... Drize Extended-Release Capsule ........................ Chlorpheniramine Maleate and Phenylpropanolamine HCl Extended-Release Capsule. Biphetap Elixir ...................................................... ANDA 88–688 .... Bromanate Elixir ................................................... ANDA 88–723 .... ANDA 88–904 .... ANDA 88–940 .... mstockstill on DSK4VPTVN1PROD with NOTICES ANDA 88–359 .... ANDA 88–681 .... Bromanate DC Syrup ........................................... Myphetane DC Syrup ........................................... Chlorpheniramine Maleate and Phenylpropanolamine HCl Extended-Release Capsule. FDA issued the notice after an epidemiologic case-control study conducted by investigators at Yale University School of Medicine (Yale Hemorrhagic Stroke Project) demonstrated an association between phenylpropanolamine (an ingredient used in prescription and over-thecounter (OTC) drug products as a nasal VerDate Mar<15>2010 18:08 Feb 19, 2014 Jkt 232001 Endo Pharmaceuticals, Inc., 500 Endo Blvd., Garden City, NY 11530. Do. Novartis Consumer Health, Inc. Do. Teva Pharmaceuticals, USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454. B. F. Ascher & Co., Inc., 15501 West 109th St., Lenexa, KS 66219. Chelsea Laboratories, 896 Orlando Ave., West Hempstead, NY 11552. Morton Grove Pharmaceuticals, Inc., 6451 Main St., Morton Grove, IL 60053. Alpharma, U.S. Pharmaceuticals Division, 333 Cassell Dr., suite 3500, Baltimore, MD 21224. Do. Morton Grove Pharmaceuticals, Inc. Geneva Pharmaceuticals, Inc., 2555 West Midway Blvd., P.O. Box 446, Broomfield, CO 80038. decongestant to relieve stuffy nose or nasal congestion and in OTC weight control drug products to control appetite) and increased risk of hemorrhagic stroke. The notice included FDA’s belief that the data from the Yale Hemorrhagic Stroke Project, taken together with spontaneous reports of hemorrhagic stroke and reports in the PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 published medical literature, provided evidence that nasal decongestant and weight control drug products containing phenylpropanolamine are no longer safe. The Director proposed to withdraw approval of the NDA and ANDA products containing phenylpropanolamine based on her conclusion that they were no longer E:\FR\FM\20FEN1.SGM 20FEN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 34 / Thursday, February 20, 2014 / Notices shown to be safe for use under the conditions that formed the basis upon which the applications were approved. In the August 14, 2001, notice, FDA provided the NDA and ANDA holders an opportunity to request a hearing to show why approval of the NDAs or ANDAs should not be withdrawn. One company, KV Pharmaceutical, requested a hearing by letter dated September 13, 2001, but that request was subsequently withdrawn by letter dated October 15, 2001. No other party requested a hearing on this matter following publication of the notice in the Federal Register. As stated above, all products listed in the notice were subsequently discontinued. Subsequent to the August 14, 2001, notice, one of the ANDAs listed in that notice was withdrawn. In a notice published in the Federal Register of February 20, 2002 (67 FR 7702), FDA withdrew approval of ANDA 71–099 for BROMATAPP Extended-Release Tablets after the application holder informed FDA that the product was no longer being marketed and requested withdrawal. In a letter to FDA dated February 25, 2013, Pfizer requested on behalf of its subsidiaries, Wyeth Pharmaceuticals, Inc. and A.H. Robins, that FDA withdraw approval of NDA 11–694 for DIMETANE–DC under § 314.150(d), noting that the product has been discontinued and is no longer marketed. In that letter, Pfizer and its named subsidiaries waived any opportunity for a hearing provided under the August 14, 2001, notice. In a response letter of March 28, 2013, the Agency acknowledged A.H. Robins’ agreement to permit FDA to withdraw approval of DIMETANE–DC under § 314.150(d) and to waive its opportunity for a hearing. For the reasons discussed in the August 14, 2001 notice, the Director, under section 505(e)(2) of the FD&C Act and under authority delegated to her by the Commissioner, finds that new evidence of clinical experience, not contained in the applications listed in table 1 and not available at the time the applications were approved, shows that phenylpropanolamine is not shown to be safe for use under the conditions of use that formed the basis upon which the applications were approved (21 U.S.C. 355(e)(2)). Therefore, approval of the NDAs listed in table 1 is hereby withdrawn. Furthermore, the Director finds that the ANDAs listed in table 1 refer to the drugs that are the subject of the NDAs listed above. Therefore, as required under section 505(j)(6) of the FD&C Act, approval of the ANDAs listed in table 1 is also withdrawn. Under 21 CFR 314.161 and 314.162(a)(1), FDA will remove the VerDate Mar<15>2010 18:08 Feb 19, 2014 Jkt 232001 products containing phenylpropanolamine named in table 1 from the list of drug products with effective approvals published in FDA’s ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations.’’ FDA will not approve or accept ANDAs that refer to these drug products. 9745 [FR Doc. 2014–03596 Filed 2–19–14; 8:45 am] 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Connie T. Jung, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301– 796–3130. SUPPLEMENTARY INFORMATION: BILLING CODE 4160–01–P I. Background Dated: February 14, 2014. Leslie Kux, Assistant Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0200] Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. Notice; establishment of docket; request for comments. ACTION: The Food and Drug Administration (FDA) is establishing a public docket to receive information and comments on standards for the interoperable exchange of information associated with transactions involving human prescription drugs in a finished dosage form (prescription drugs) to comply with new requirements in the Drug Supply Chain Security Act (DSCSA). We are seeking information from drug manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies) and other drug supply chain stakeholders and interested parties, including standards organizations, State and Federal Agencies, and solution providers. In particular, stakeholders and other interested parties are requested to comment about the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, for each transfer of product in which a change of ownership occurs. This action is related to FDA’s implementation of the DSCSA. DATES: Submit either electronic or written comments by April 21, 2014. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. SUMMARY: PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 On November 27, 2013, the DSCSA (Title II, Pub. L. 113–54) was signed into law. The DSCSA outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States. Section 202 of the DSCSA, which adds section 582 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), directs the Secretary of Health and Human Services (the Secretary) to establish standards for the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, in consultation with other appropriate Federal officials, manufacturers, repackagers, wholesale drug distributors, dispensers, and other pharmaceutical distribution supply chain stakeholders. FDA has been engaged in efforts to improve the security of the drug supply chain for many years to protect U.S. patients from unsafe, ineffective, and poor quality drugs. Since the formation of the first FDA Counterfeit Drug Task Force in 2003, FDA has strongly advocated for a multilayered approach to securing the supply chain and protecting consumers from the threats posed by counterfeit and diverted drugs. The ability to track and trace finished prescription drugs plays a significant role in providing transparency and accountability in the drug supply chain. Under section 505D of the FD&C Act (21 U.S.C. 355e), FDA has been evaluating existing and emerging standards, system attributes and needs, and adoption of track and trace and authentication systems and technology. The system that will be established under DSCSA will enhance FDA’s ability to help protect U.S. consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful by improving detection and removal of potentially dangerous drugs from the drug supply chain. FDA is announcing the establishment of a public docket to provide an opportunity for interested persons to E:\FR\FM\20FEN1.SGM 20FEN1

Agencies

[Federal Register Volume 79, Number 34 (Thursday, February 20, 2014)]
[Notices]
[Pages 9744-9745]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03596]

[[Page 9744]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-N-0274 (formerly 01N-0196)]

Phenylpropanolamine; Withdrawal of Approval of 13 New Drug
Applications and 7 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 13 new drug applications (NDAs) and 7 abbreviated new drug
applications (ANDAs) for products containing phenylpropanolamine. The
basis for the withdrawals is that the products are no longer considered
safe due to the association of phenylpropanolamine use with increased
risk of hemorrhagic stroke. The holders of these NDAs and ANDAs have
waived their opportunity for a hearing.

DATES: Effective February 20, 2014.

FOR FURTHER INFORMATION CONTACT: Emily Helms Williams, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3381.

SUPPLEMENTARY INFORMATION: On November 3, 2000, the Director of FDA's
Center for Drug Evaluation and Research (the Director) sent a letter to
holders of NDAs and ANDAs for drug products containing
phenylpropanolamine requesting that they voluntarily discontinue
marketing any such products due to developments indicating an
association between phenylpropanolamine use and increased risk of
hemorrhagic stroke. Subsequently, in a notice published in the Federal
Register on August 14, 2001 (66 FR 42665), the Director offered an
opportunity for a hearing on a proposal to issue an order, under
section 505(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 355(e)) and 21 CFR 314.150(a)(2), withdrawing approval
of 13 NDAs and 8 ANDAs for products containing phenylpropanolamine.
(Although the August 14, 2001, notice stated that FDA proposed to
withdraw approval of 16 NDAs and 8 ANDAs, the notice listed only 13
NDAs and 8 ANDAs.) The following products, all of which have been
discontinued, were listed in the notice:

Table 1--NDAs and ANDAs for Which FDA Has Proposed To Withdraw Approval of the Applications
----------------------------------------------------------------------------------------------------------------
Application No. Drug Applicant
----------------------------------------------------------------------------------------------------------------
NDA 11-694....................... Dimetane-DC Syrup................ A.H. Robins Co., P.O. Box 8299,
Philadelphia, PA 19101.
NDA 12-152....................... Ornade Extended-Release Tablet... SmithKline-Beecham, 1250 South
Collegeville Rd., P.O. Box 5089,
Collegeville, PA 19426.
NDA 12-436....................... Dimetapp Extended-Release Tablet. Whitehall-Robins, 5 Giralda Farms,
Madison, NJ 07940.
NDA 13-087....................... Dimetapp Elixir.................. Do.
NDA 18-050....................... Corsym Extended-Release Medeva Americas, Inc., 755 Jefferson Rd.,
Suspension. P.O. Box 1710, Rochester, NY 14603.
NDA 18-099....................... Contac Extended-Release Capsule.. SmithKline Beecham Consumer Health, L.P.,
1500 Littleton Rd., Parsippany, NJ 07054.
NDA 18-298....................... Tavist-D Extended-Release Tablet. Novartis Consumer Health, Inc., 560 Morris
Ave., Summit, NJ 07901.
NDA 18-556....................... Demazin Extended-Release Tablet.. Schering-Plough HealthCare Products, Three
Oak Way, P.O. Box 603, Berkeley Heights,
NJ 07922.
NDA 18-809....................... Phenylpropanolamine Hydrochloride Schwarz Pharma, 6140 West Executive Dr.,
(HCl) Chlorpheniramine Maleate Mequon, WI 53092.
Extended-Release Capsule.
NDA 19-410....................... Hycomine Syrup................... Endo Pharmaceuticals, Inc., 500 Endo
Blvd., Garden City, NY 11530.
NDA 19-411....................... Hycomine Pediatric Syrup......... Do.
NDA 19-613....................... Contac Extended-Release Tablet... Novartis Consumer Health, Inc.
NDA 20-640....................... Tavist-D Extended-Release Tablet. Do.
ANDA 71-099...................... Bromatapp Extended-Release Tablet Teva Pharmaceuticals, USA, 1090 Horsham
Rd., P.O. Box 1090, North Wales, PA
19454.
ANDA 88-359...................... Drize Extended-Release Capsule... B. F. Ascher & Co., Inc., 15501 West 109th
St., Lenexa, KS 66219.
ANDA 88-681...................... Chlorpheniramine Maleate and Chelsea Laboratories, 896 Orlando Ave.,
Phenylpropanolamine HCl Extended- West Hempstead, NY 11552.
Release Capsule.
ANDA 88-687...................... Biphetap Elixir.................. Morton Grove Pharmaceuticals, Inc., 6451
Main St., Morton Grove, IL 60053.
ANDA 88-688...................... Bromanate Elixir................. Alpharma, U.S. Pharmaceuticals Division,
333 Cassell Dr., suite 3500, Baltimore,
MD 21224.
ANDA 88-723...................... Bromanate DC Syrup............... Do.
ANDA 88-904...................... Myphetane DC Syrup............... Morton Grove Pharmaceuticals, Inc.
ANDA 88-940...................... Chlorpheniramine Maleate and Geneva Pharmaceuticals, Inc., 2555 West
Phenylpropanolamine HCl Extended- Midway Blvd., P.O. Box 446, Broomfield,
Release Capsule. CO 80038.
----------------------------------------------------------------------------------------------------------------

FDA issued the notice after an epidemiologic case-control study
conducted by investigators at Yale University School of Medicine (Yale
Hemorrhagic Stroke Project) demonstrated an association between
phenylpropanolamine (an ingredient used in prescription and over-the-
counter (OTC) drug products as a nasal decongestant to relieve stuffy
nose or nasal congestion and in OTC weight control drug products to
control appetite) and increased risk of hemorrhagic stroke. The notice
included FDA's belief that the data from the Yale Hemorrhagic Stroke
Project, taken together with spontaneous reports of hemorrhagic stroke
and reports in the published medical literature, provided evidence that
nasal decongestant and weight control drug products containing
phenylpropanolamine are no longer safe. The Director proposed to
withdraw approval of the NDA and ANDA products containing
phenylpropanolamine based on her conclusion that they were no longer

[[Page 9745]]

shown to be safe for use under the conditions that formed the basis
upon which the applications were approved.
In the August 14, 2001, notice, FDA provided the NDA and ANDA
holders an opportunity to request a hearing to show why approval of the
NDAs or ANDAs should not be withdrawn. One company, KV Pharmaceutical,
requested a hearing by letter dated September 13, 2001, but that
request was subsequently withdrawn by letter dated October 15, 2001. No
other party requested a hearing on this matter following publication of
the notice in the Federal Register. As stated above, all products
listed in the notice were subsequently discontinued.
Subsequent to the August 14, 2001, notice, one of the ANDAs listed
in that notice was withdrawn. In a notice published in the Federal
Register of February 20, 2002 (67 FR 7702), FDA withdrew approval of
ANDA 71-099 for BROMATAPP Extended-Release Tablets after the
application holder informed FDA that the product was no longer being
marketed and requested withdrawal.
In a letter to FDA dated February 25, 2013, Pfizer requested on
behalf of its subsidiaries, Wyeth Pharmaceuticals, Inc. and A.H.
Robins, that FDA withdraw approval of NDA 11-694 for DIMETANE-DC under
Sec. 314.150(d), noting that the product has been discontinued and is
no longer marketed. In that letter, Pfizer and its named subsidiaries
waived any opportunity for a hearing provided under the August 14,
2001, notice. In a response letter of March 28, 2013, the Agency
acknowledged A.H. Robins' agreement to permit FDA to withdraw approval
of DIMETANE-DC under Sec. 314.150(d) and to waive its opportunity for
a hearing.
For the reasons discussed in the August 14, 2001 notice, the
Director, under section 505(e)(2) of the FD&C Act and under authority
delegated to her by the Commissioner, finds that new evidence of
clinical experience, not contained in the applications listed in table
1 and not available at the time the applications were approved, shows
that phenylpropanolamine is not shown to be safe for use under the
conditions of use that formed the basis upon which the applications
were approved (21 U.S.C. 355(e)(2)). Therefore, approval of the NDAs
listed in table 1 is hereby withdrawn. Furthermore, the Director finds
that the ANDAs listed in table 1 refer to the drugs that are the
subject of the NDAs listed above. Therefore, as required under section
505(j)(6) of the FD&C Act, approval of the ANDAs listed in table 1 is
also withdrawn.
Under 21 CFR 314.161 and 314.162(a)(1), FDA will remove the
products containing phenylpropanolamine named in table 1 from the list
of drug products with effective approvals published in FDA's ``Approved
Drug Products With Therapeutic Equivalence Evaluations.'' FDA will not
approve or accept ANDAs that refer to these drug products.

Dated: February 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03596 Filed 2-19-14; 8:45 am]
BILLING CODE 4160-01-P

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