80 FR 58490 - Determination That PONDIMIN (Fenfluramine Hydrochloride) Tablets, 20 Milligrams and 60 Milligrams, and PONDEREX (Fenfluramine Hydrochloride) Capsules, 20 Milligrams Were Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 188 (September 29, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 188 (September 29, 2015)
| Page Range | 58490-58491 | |
| FR Document | 2015-24619 |
[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)] [Notices] [Pages 58490-58491] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24619] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3389] Determination That PONDIMIN (Fenfluramine Hydrochloride) Tablets, 20 Milligrams and 60 Milligrams, and PONDEREX (Fenfluramine Hydrochloride) Capsules, 20 Milligrams Were Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that PONDIMIN (fenfluramine hydrochloride (HCl)) tablets, 20 milligrams (mg) and 60 mg, and PONDEREX (fenfluramine HCl) capsules, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for fenfluramine HCl tablets, 20 mg or 60 mg, or fenfluramine HCl capsules, 20 mg. FOR FURTHER INFORMATION CONTACT: Robin Fastenau, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 240- 402-4510. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ``listed drug,'' which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ``Approved Drug Products With Therapeutic Equivalence Evaluations,'' which is known generally as the ``Orange Book.'' Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. [[Page 58491]] PONDIMIN (fenfluramine HCl) tablets, 20 mg, and PONDEREX (fenfluramine HCl) capsules, 20 mg, were the subject of NDA 16-618, held by Wyeth Pharmaceuticals, and were initially approved on June 14, 1973. PONDIMIN (fenfluramine HCl) sustained release tablets, 60 mg, was the subject of NDA 16-618, held by Wyeth Pharmaceuticals, and was initially approved in 1982. PONDIMIN and PONDEREX were indicated for treatment of obesity. In 1997, FDA asked that PONDIMIN (fenfluramine HCl) tablets and PONDEREX (fenfluramine HCl) capsules be withdrawn from the market after receiving new evidence that the products were associated with valvular heart disease (September 15, 1997, FDA Announces Withdrawal Fenfluramine and Dexfenfluramine (Fen-Phen), available on the Internet at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm179871.htm; see FDA November 1997 Fen-Phen Safety Update Information, available on the Internet at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm072820.htm). Wyeth Pharmaceuticals subsequently discontinued marketing these products. On October 8, 1998, FDA issued a Notice of Proposed Rulemaking proposing to include certain drug products on a list of drug products that had been withdrawn or removed from the market because such drugs products or components of such drug products had been found to be unsafe or not effective, and which could not be compounded under section 503A of the FD&C Act (63 FR 54082). FDA identified in that notice ``all drug products containing fenfluramine hydrochloride.'' The notice also noted that fenfluramine HCl tablets, formerly marketed as PONDIMIN tablets, were associated with valvular heart disease, and the manufacturer voluntarily withdrew the drug from the market. This proposed rule was finalized in 64 FR 10944 (March 8, 1999), 21 CFR 216.24. In the Federal Register of May 5, 2004 (69 FR 25124), FDA issued a notice that it was withdrawing approval of 92 new drug applications and 49 abbreviated new drug applications, including PONDIMIN (fenfluramine HCl) tablets and PONDEREX (fenfluramine HCl) capsules, under section 505(e) of the FD&C Act. Consistent with Sec. 314.161 and its prior rulemaking on compounded drug products under 21 CFR 216.24, FDA has determined that PONDIMIN (fenfluramine HCl) tablets and PONDEREX (fenfluramine HCl) capsules were withdrawn from sale for reasons of safety or effectiveness. This determination is consistent with FDA's prior request and Wyeth Pharmaceutical's withdrawal of PONDIMIN (fenfluramine HCl) tablets and PONDEREX (fenfluramine HCl) capsules from the market for reasons of safety or effectiveness. The Agency previously removed PONDIMIN (fenfluramine HCl) tablets and PONDEREX (fenfluramine HCl) capsules from the list of drug products published in the Orange Book. FDA will not accept or approve any ANDAs that refer to these drug products. Dated: September 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-24619 Filed 9-28-15; 8:45 am] BILLING CODE 4164-01-P
![58490 Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices
exceptions, show that the drug for Therapeutic Equivalence Evaluations,’’ voluntarily withdrawn from sale and
which they are seeking approval which is generally known as the ANDAs that refer to the listed drug have
contains the same active ingredient in ‘‘Orange Book’’. Under FDA regulations, been approved, and (3) when a person
the same strength and dosage form as a drug is removed from the list if the petitions for such a determination under
the ‘‘listed drug,’’ which is a version of Agency withdraws or suspends 21 CFR 10.25(a) and 10.30. Section
the drug that was previously approved. approval of the drug’s NDA or ANDA 314.161(d) provides that if FDA
ANDA applicants do not have to repeat for reasons of safety or effectiveness or determines that a listed drug was
the extensive clinical testing otherwise if FDA determines that the listed drug withdrawn from sale for safety or
necessary to gain approval of a new was withdrawn from sale for reasons of effectiveness reasons, the Agency will
drug application (NDA). safety or effectiveness (21 CFR 314.162).
initiate proceedings that could result in
The 1984 amendments include what Under § 314.161(a) (21 CFR
is now section 505(j)(7) of the Federal 314.161(a)), the Agency must determine the withdrawal of approval of the
Food, Drug, and Cosmetic Act (21 U.S.C. whether a listed drug was withdrawn ANDAs that refer to the listed drug.
355(j)(7)), which requires FDA to from sale for reasons of safety or FDA has become aware that the drug
publish a list of all approved drugs. effectiveness: (1) Before an ANDA that product listed in the table in this
FDA publishes this list as part of the refers to that listed drug may be document is no longer being marketed.
‘‘Approved Drug Products with approved, (2) whenever a listed drug is
Application No. Drug Applicant
NDA 21–180 ........................ ORTHO EVRA (norelgestromin/ethinyl estradiol) Janssen Pharmaceutical Inc., 920 U.S. Highway 202,
Transdermal System; 0.15 mg/24hr norelgestromin Raritan, NJ 08869–0602.
and 0.035 mg/24hr ethinyl estradiol.
FDA has reviewed its records and, DEPARTMENT OF HEALTH AND versions of drug products under an
under § 314.161, has determined that HUMAN SERVICES ANDA procedure. ANDA applicants
the drug product listed in this document must, with certain exceptions, show that
was not withdrawn from sale for reasons Food and Drug Administration the drug for which they are seeking
of safety or effectiveness. Accordingly, [Docket No. FDA–2015–N–3389] approval contains the same active
the Agency will continue to list the drug ingredient in the same strength and
product listed in this document in the Determination That PONDIMIN dosage form as the ‘‘listed drug,’’ which
‘‘Discontinued Drug Product List’’ (Fenfluramine Hydrochloride) Tablets, is a version of the drug that was
section of the Orange Book. The 20 Milligrams and 60 Milligrams, and previously approved. ANDA applicants
‘‘Discontinued Drug Product List’’ PONDEREX (Fenfluramine do not have to repeat the extensive
identifies, among other items, drug Hydrochloride) Capsules, 20 clinical testing otherwise necessary to
products that have been discontinued Milligrams Were Withdrawn From Sale gain approval of a new drug application
from marketing for reasons other than for Reasons of Safety or Effectiveness (NDA).
safety or effectiveness. AGENCY: Food and Drug Administration, The 1984 amendments include what
HHS. is now section 505(j)(7) of the Federal
Approved ANDAs that refer to the
ACTION: Notice. Food, Drug, and Cosmetic Act (FD&C
NDA listed in this document are
Act) (21 U.S.C. 355(j)(7)), which
unaffected by the discontinued requires FDA to publish a list of all
SUMMARY: The Food and Drug
marketing of the product subject to this approved drugs. FDA publishes this list
Administration (FDA or Agency) has
NDA. Additional ANDAs that refer to determined that PONDIMIN as part of the ‘‘Approved Drug Products
this product may also be approved by (fenfluramine hydrochloride (HCl)) With Therapeutic Equivalence
the Agency if they comply with relevant tablets, 20 milligrams (mg) and 60 mg, Evaluations,’’ which is known generally
legal and regulatory requirements. If and PONDEREX (fenfluramine HCl) as the ‘‘Orange Book.’’ Under FDA
FDA determines that labeling for capsules, 20 mg, were withdrawn from regulations, drugs are removed from the
norelgestromin/ethinyl estradiol sale for reasons of safety or list if the Agency withdraws or
transdermal system should be revised to effectiveness. The Agency will not suspends approval of the drug’s NDA or
meet current standards, the Agency will accept or approve abbreviated new drug ANDA for reasons of safety or
advise ANDA applicants to submit such applications (ANDAs) for fenfluramine effectiveness or if FDA determines that
labeling. HCl tablets, 20 mg or 60 mg, or the listed drug was withdrawn from sale
Dated: September 23, 2015. fenfluramine HCl capsules, 20 mg. for reasons of safety or effectiveness (21
FOR FURTHER INFORMATION CONTACT: CFR 314.162).
Leslie Kux,
Robin Fastenau, Center for Drug A person may petition the Agency to
Associate Commissioner for Policy.
Evaluation and Research, Food and determine, or the Agency may
[FR Doc. 2015–24622 Filed 9–28–15; 8:45 am] Drug Administration, 10903 New determine on its own initiative, whether
BILLING CODE 4164–01–P Hampshire Ave., Bldg. 51, Rm. 6236, a listed drug was withdrawn from sale
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Silver Spring, MD 20993–0002, 240– for reasons of safety or effectiveness.
402–4510. This determination may be made at any
SUPPLEMENTARY INFORMATION: In 1984, time after the drug has been withdrawn
Congress enacted the Drug Price from sale, but must be made prior to
Competition and Patent Term approving an ANDA that refers to the
Restoration Act of 1984 (Pub. L. 98–417) listed drug (§ 314.161 (21 CFR 314.161)).
(the 1984 amendments), which FDA may not approve an ANDA that
authorized the approval of duplicate does not refer to a listed drug.
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![Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices 58491
PONDIMIN (fenfluramine HCl) and PONDEREX (fenfluramine HCl) INFORMATION section for electronic
tablets, 20 mg, and PONDEREX capsules were withdrawn from sale for access to the guidance document.
(fenfluramine HCl) capsules, 20 mg, reasons of safety or effectiveness. This Submit electronic comments on the
were the subject of NDA 16–618, held determination is consistent with FDA’s guidance to http://www.regulations.gov.
by Wyeth Pharmaceuticals, and were prior request and Wyeth Submit written comments to the
initially approved on June 14, 1973. Pharmaceutical’s withdrawal of Division of Dockets Management (HFA–
PONDIMIN (fenfluramine HCl) PONDIMIN (fenfluramine HCl) tablets 305), Food and Drug Administration,
sustained release tablets, 60 mg, was the and PONDEREX (fenfluramine HCl) 5630 Fishers Lane, Rm. 1061, Rockville,
subject of NDA 16–618, held by Wyeth capsules from the market for reasons of MD 20852.
Pharmaceuticals, and was initially safety or effectiveness. The Agency FOR FURTHER INFORMATION CONTACT:
approved in 1982. PONDIMIN and previously removed PONDIMIN Maryll Toufanian, Center for Drug
PONDEREX were indicated for (fenfluramine HCl) tablets and Evaluation and Research, Food and
treatment of obesity. PONDEREX (fenfluramine HCl) capsules Drug Administration, 10903 New
In 1997, FDA asked that PONDIMIN from the list of drug products published Hampshire Ave, Bldg. 75, Rm. 1684,
(fenfluramine HCl) tablets and in the Orange Book. FDA will not accept Silver Spring, MD 20993–0002, 240–
PONDEREX (fenfluramine HCl) capsules or approve any ANDAs that refer to 402–7944, Maryll.Toufanian@fda.
be withdrawn from the market after these drug products. hhs.gov.
receiving new evidence that the
Dated: September 23, 2015. SUPPLEMENTARY INFORMATION:
products were associated with valvular
heart disease (September 15, 1997, FDA Leslie Kux,
I. Background
Announces Withdrawal Fenfluramine Associate Commissioner for Policy.
and Dexfenfluramine (Fen-Phen), [FR Doc. 2015–24619 Filed 9–28–15; 8:45 am] FDA is announcing the availability of
available on the Internet at http:// BILLING CODE 4164–01–P
a guidance for industry entitled
www.fda.gov/Drugs/DrugSafety/Post ‘‘Controlled Correspondence Related to
marketDrugSafetyInformationfor Generic Drug Development’’. The
PatientsandProviders/ucm179871.htm; DEPARTMENT OF HEALTH AND guidance document provides
see FDA November 1997 Fen-Phen HUMAN SERVICES information regarding the process by
Safety Update Information, available on which human generic drug
the Internet at http://www.fda.gov/ Food and Drug Administration manufacturers and related industry can
Drugs/DrugSafety/PostmarketDrug submit correspondence to FDA
SafetyInformationforPatientsand [Docket No. FDA–2014–D–1167] requesting information on generic drug
Providers/ucm072820.htm). Wyeth development. This guidance also
Controlled Correspondence Related to describes FDA’s process for providing
Pharmaceuticals subsequently
Generic Drug Development; Guidance communications related to such
discontinued marketing these products.
for Industry; Availability correspondence.
On October 8, 1998, FDA issued a
Notice of Proposed Rulemaking AGENCY: Food and Drug Administration, Under the provisions of the Generic
proposing to include certain drug HHS. Drug User Fee Amendments of 2012
products on a list of drug products that (GDUFA), FDA agreed to certain
ACTION: Notice. obligations as laid out in the Generic
had been withdrawn or removed from
the market because such drugs products SUMMARY: The Food and Drug Drug User Fee Act Program Performance
or components of such drug products Administration (FDA or Agency) is Goals and Procedures for fiscal years
had been found to be unsafe or not announcing the availability of a 2013 through 2017 (the GDUFA
effective, and which could not be guidance for industry entitled Commitment Letter) that accompanies
compounded under section 503A of the ‘‘Controlled Correspondence Related to the legislation (Ref. 1). Among those
FD&C Act (63 FR 54082). FDA identified Generic Drug Development’’. The obligations is FDA’s commitment to
in that notice ‘‘all drug products guidance document provides performance metrics for its responses to
containing fenfluramine information regarding the process by controlled correspondence for fiscal
hydrochloride.’’ The notice also noted which human generic drug years 2015 through 2017.
that fenfluramine HCl tablets, formerly manufacturers and related industry can This guidance finalizes the draft
marketed as PONDIMIN tablets, were submit correspondence to FDA guidance announced in the Federal
associated with valvular heart disease, requesting information on generic drug Register on August 27, 2014 (79 FR
and the manufacturer voluntarily development. This guidance also 51180). The Agency considered
withdrew the drug from the market. describes FDA’s process for providing comments on the draft guidance while
This proposed rule was finalized in 64 communications related to such finalizing this guidance. Generally, we
FR 10944 (March 8, 1999), 21 CFR correspondence. revised the draft guidance to provide
216.24. clarifying and explanatory information
In the Federal Register of May 5, 2004 DATES: Submit either electronic or that will assist human generic drug
(69 FR 25124), FDA issued a notice that written comments on Agency guidances manufacturers and related industry as
it was withdrawing approval of 92 new at any time. they submit controlled correspondence
drug applications and 49 abbreviated ADDRESSES: Submit written requests for to FDA. Changes from the draft
new drug applications, including single copies of this guidance to the guidance include a description of a
asabaliauskas on DSK5VPTVN1PROD with NOTICES
PONDIMIN (fenfluramine HCl) tablets Division of Drug Information, Center for process to submit information to update
and PONDEREX (fenfluramine HCl) Drug Evaluation and Research, Food the Agency’s Inactive Ingredient
capsules, under section 505(e) of the and Drug Administration, 10001 New Database and a description of enhanced
FD&C Act. Consistent with § 314.161 Hampshire Ave., Hillandale Building, communication to requestors regarding
and its prior rulemaking on 4th Floor, Silver Spring, MD 20993– the status of their controlled
compounded drug products under 21 0002. Send one self-addressed adhesive correspondence.
CFR 216.24, FDA has determined that label to assist that office in processing Two comment threads on the draft
PONDIMIN (fenfluramine HCl) tablets your requests. See the SUPPLEMENTARY guidance benefit from additional
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Document Created: 2015-12-15 09:47:01
Document Modified: 2015-12-15 09:47:01
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Robin Fastenau, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 240- 402-4510. | |
| FR Citation | 80 FR 58490 |
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