Pfizer, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications, 47566-47567 [2024-12065]
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Federal Register / Vol. 89, No. 107 / Monday, June 3, 2024 / Notices
available by prescription, and may
cause serious side effects for those
suffering from cardiovascular disease,
hypertension, bleeding disorders, and
other related health conditions. The
drugs Mr. Punjani imported and resold
had not been approved by the FDA
meaning that they did not have the same
assurance of safety or efficacy as FDA
approved drugs. Mr. Punjani would use
commercial shippers to ship the tablets
from India to his home where Mr.
Punjani would organize them in order to
resell them to wholesale businesses and
convenience stores in Georgia. The
labeling on the drugs Mr. Punjani resold
did not contain adequate directions for
use and he dispensed these prescription
drugs without the prescription of a
practitioner licensed by law to
administer the drugs. At one point,
Customs and Border Patrol (CBP) sent
Mr. Punjani a notice warning him that
pills he had offered for import had been
seized because they were in violation of
the FD&C Act. Mr. Punjani ignored this
notice and others CBP and FDA later
sent him. Ultimately Mr. Punjani
imported thousands of illegal pills over
several years.
As a result of this conviction, FDA
sent Mr. Punjani, by certified mail, on
January 30, 2024, a notice proposing to
debar him for a 5-year period from
importing or offering for import any
drug into the United States. The
proposal was based on a finding under
section 306(b)(3)(C) of the FD&C Act
that Mr. Punjani’s felony conviction
under Federal law for Conspiracy to
Defraud the United States in violation of
18 U.S.C. 371, was for conduct relating
to the importation into the United States
of any drug or controlled substance
because Mr. Punjani illegally imported
and introduced unapproved and
misbranded prescription drug products
into interstate commerce. In proposing a
debarment period, FDA weighed the
considerations set forth in section
306(c)(3) of the FD&C Act that it
considered applicable to Mr. Punjani’s
offense and concluded that the offense
warranted the imposition of a 5-year
period of debarment.
The proposal informed Mr. Punjani of
the proposed debarment and offered
him an opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Mr.
Punjani received the proposal and
notice of opportunity for a hearing on
February 5, 2024. Mr. Punjani failed to
request a hearing within the timeframe
prescribed by regulation and has,
therefore, waived his opportunity for a
hearing and waived any contentions
concerning his debarment (21 CFR part
12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Shanif
Abdul Punjani has been convicted of a
felony under Federal law for conduct
relating to the importation into the
United States of any drug or controlled
substance. FDA finds that the offense
should be accorded a debarment period
of 5 years as provided by section
306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding,
Mr. Punjani is debarred for a period of
5 years from importing or offering for
import any drug into the United States,
effective (see DATES). Pursuant to section
301(cc) of the FD&C Act (21 U.S.C.
331(cc)), the importing or offering for
import into the United States of any
drug by, with the assistance of, or at the
direction of Mr. Punjani is a prohibited
act.
Dated: May 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2462]
Pfizer, Inc., et al.; Withdrawal of
Approval of 23 New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 23 new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
SUMMARY:
Approval is withdrawn as of July
3, 2024.
DATES:
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
The
applicants listed in table 1 have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2024–12064 Filed 5–31–24; 8:45 am]
BILLING CODE 4164–01–P
TABLE 1—NDAS FOR WHICH APPROVAL IS WITHDRAWN
Application No.
Drug
Applicant
NDA 012427 ......
Didrex (benzfetamine hydrogen chloride (HCl)) Tablets, 25
milligrams (mg) and 50 mg.
Clomid (clomiphene citrate) Tablets, 50 mg ............................
Pfizer, Inc., 66 Hudson Boulevard East, New York, NY
10001.
Sanofi US Services Inc., C/O Sanofi-Aventis U.S. LLC, 55
Corporate Dr., Bridgewater, NJ 08807.
Do.
lotter on DSK11XQN23PROD with NOTICES1
NDA 016131 ......
NDA 016584 ......
NDA 019032 ......
Navane (thiothixene HCl) Capsules, 1 mg, 2 mg, 5 mg, 10
mg, and 20 mg.
Tenex (guanfacine HCl) Tablets, 1 mg, 2 mg, and 3 mg ........
NDA 019776 ......
Concentraid (desmopressin acetate) Nasal Solution, 0.01% ..
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Promius Pharma, LLC, C/O Dr. Reddy’s Laboratories Inc.,
107 College Rd. East, Princeton, NJ 08540.
Ferring Pharmaceuticals Inc., 100 Interpace Parkway, Parsippany, NJ 07054.
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Federal Register / Vol. 89, No. 107 / Monday, June 3, 2024 / Notices
47567
TABLE 1—NDAS FOR WHICH APPROVAL IS WITHDRAWN—Continued
Application No.
Drug
Applicant
NDA 019826 ......
B. Braun Medical Inc, 901 Marcon Blvd., Allentown, PA
18109.
NDA 020928 ......
Theophylline and Dextrose 5% Injections in Plastic Container, 40 mg/100 milliliters (mL), 80 mg/100 mL, 160 mg/
100 mL, 200 mg/100 mL, 320 mg/100 mL, and 400 mg/
100 mL.
Norvir (ritonavir) Oral Solution, 80 mg/mL ...............................
Emadine (emedastine difumarate) Ophthalmic Solution,
0.05%.
Aggrenox (aspirin and dipyridamole) Extended-Release Capsules, 25 mg/200 mg.
Glucagon Injection, 1 mg/vial ...................................................
NDA 020972 ......
Sustiva (efavirenz) Capsules, 50 mg, 100 mg, and 200 mg ...
NDA 021400 ......
NDA 021449 ......
Levitra (vardenafil HCI) Tablets, 2.5 mg, 5 mg, 10 mg, and
20 mg.
Hepsera (adefovir dipivoxil) Tablets, 10 mg ............................
NDA 021623 ......
Synera (lidocaine and tetracaine) Patch, 70 mg/70 mg ..........
NDA 022331 ......
Kapvay (clonidine HCl) Extended-Release Tablets, 0.1 mg
and 0.2 mg.
Jenloga (clonidine HCl) Extended-Release Tablets, 0.1 mg
and 0.2 mg.
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
Tablets, 600 mg/300 mg/300 mg.
NDA 020659 ......
NDA 020706 ......
NDA 020884 ......
NDA 022343 ......
NDA 022344 ......
NDA 205004 ......
Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 300
mg/300 mg.
Staxyn (vardenafil HCl) Orally Disintegrating Tablets, 10 mg
Durlaza (aspirin) Extended-Release Capsules, 162.5 mg ......
Radiogenix System (technetium Tc-99m generator) For the
Production of Sodium Pertechnetate Tc 99m Injection, Intravenous, Intravesicular, and Ophthalmic Solution, 30–
1153 millicurie/Generator.
Bortezomib Powder for Injection, 3.5 mg/vial ..........................
NDA 205787 ......
Evzio (naloxone HCl) Solution for Injection, 0.4 mg/0.4 mL ...
NDA 209862 ......
Evzio (naloxone HCl) Auto-Injector for Injection, 2 mg/0.4 mL
lotter on DSK11XQN23PROD with NOTICES1
NDA 200179 ......
NDA 200671 ......
NDA 202158 ......
Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn as of July 3, 2024.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms included in the
application but inadvertently missing
from table 1. Introduction or delivery for
introduction into interstate commerce of
products listed in table 1 without an
approved new drug application violates
sections 505(a) and 301(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)). Drug products that
are listed in table 1 that are in inventory
on July 3, 2024 may continue to be
dispensed until the inventories have
been depleted or the drug products have
reached their expiration dates or
otherwise become violative, whichever
occurs first.
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18:00 May 31, 2024
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AbbVie Inc. 1 N. Waugekan Rd., North Chicago, IL 60064.
Novartis Pharmaceuticals Co., 1 Health Plaza, East Hanover,
NJ 07936–1080
Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury
Rd, Ridgefield, CT 06877.
Eli Lilly and Company, Lilly Corporate Center, Indianapolis,
IN 46285.
Bristol-Myers Squibb Company, P.O. Box 4000, Princeton,
NJ 08543–4000.
Bayer HealthCare Pharmaceuticals Inc.
Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA
94404.
Galen Specialty Pharma US, LLC, 25 Fretz Rd., Souderton,
PA 18694.
Concordia Pharmaceuticals, Inc C/O Cardinal Health Reg
Sciences, 7400 West 110th St., Suite 150, Overland Park,
KS 66210.
Aurobindo Pharma Limited C/O Aurobindo Pharma USA,
Inc., 279 Princeton-Highstown Rd., East Windsor, NJ
08520.
Do.
Bayer HealthCare Pharmaceuticals, Inc.
HESP LLC, 312 Farmington Ave., Farmington, CT 06032.
NorthStar Medical Radioisotopes, LLC, 1800 Gateway Blvd.,
Beloit, WI 53511.
Fresenius Kabi USA, LLC, 3 Corporate Dr., Lake Zurich, IL
60047.
Kaleo, Inc., 111 Virginia St., Suite 300, Richmond, VA
23219.
Do.
Dated: May 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–12065 Filed 5–31–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
Food and Drug Administration,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA), Office of the
Commissioner, Headquarters
organizations, and Centers have
modified their organizational structure
DATES: This organization was approved
by the Secretary of Health and Human
SUMMARY:
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Services on March 5, 2024, and became
effective on May 13, 2024.
FOR FURTHER INFORMATION CONTACT:
Yashika Rahaman, Director, Office of
Planning, Evaluation, and Risk
Management, Office of the Finance,
Budget, Acquisitions and Planning,
Food and Drug Administration, 10903
New Hampshire Avenue, WO32, Room
4216, Silver Spring, MD 20993, 301–
796–4710.
Part D,
Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970; 60 FR 56606, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007; 74 FR 41713, August
18, 2009, 76 FR 45270, July 28, 2011,
and 84 FR 22854, May 20, 2019) is
amended to reflect the approved Food
and Drug Administration’s Human
Foods reorganization.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\03JNN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 107 (Monday, June 3, 2024)]
[Notices]
[Pages 47566-47567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12065]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2462]
Pfizer, Inc., et al.; Withdrawal of Approval of 23 New Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 23 new drug applications (NDAs) from multiple
applicants. The applicants notified the Agency in writing that the drug
products were no longer marketed and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of July 3, 2024.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].
SUPPLEMENTARY INFORMATION: The applicants listed in table 1 have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have
also, by their requests, waived their opportunity for a hearing.
Withdrawal of approval of an application or abbreviated application
under Sec. 314.150(c) is without prejudice to refiling.
Table 1--NDAs for Which Approval Is Withdrawn
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 012427............. Didrex (benzfetamine Pfizer, Inc., 66
hydrogen chloride Hudson Boulevard
(HCl)) Tablets, 25 East, New York, NY
milligrams (mg) and 50 10001.
mg.
NDA 016131............. Clomid (clomiphene Sanofi US Services
citrate) Tablets, 50 Inc., C/O Sanofi-
mg. Aventis U.S. LLC, 55
Corporate Dr.,
Bridgewater, NJ
08807.
NDA 016584............. Navane (thiothixene Do.
HCl) Capsules, 1 mg, 2
mg, 5 mg, 10 mg, and
20 mg.
NDA 019032............. Tenex (guanfacine HCl) Promius Pharma, LLC, C/
Tablets, 1 mg, 2 mg, O Dr. Reddy's
and 3 mg. Laboratories Inc.,
107 College Rd. East,
Princeton, NJ 08540.
NDA 019776............. Concentraid Ferring
(desmopressin acetate) Pharmaceuticals Inc.,
Nasal Solution, 0.01%. 100 Interpace
Parkway, Parsippany,
NJ 07054.
[[Page 47567]]
NDA 019826............. Theophylline and B. Braun Medical Inc,
Dextrose 5% Injections 901 Marcon Blvd.,
in Plastic Container, Allentown, PA 18109.
40 mg/100 milliliters
(mL), 80 mg/100 mL,
160 mg/100 mL, 200 mg/
100 mL, 320 mg/100 mL,
and 400 mg/100 mL.
NDA 020659............. Norvir (ritonavir) Oral AbbVie Inc. 1 N.
Solution, 80 mg/mL. Waugekan Rd., North
Chicago, IL 60064.
NDA 020706............. Emadine (emedastine Novartis
difumarate) Ophthalmic Pharmaceuticals Co.,
Solution, 0.05%. 1 Health Plaza, East
Hanover, NJ 07936-
1080
NDA 020884............. Aggrenox (aspirin and Boehringer Ingelheim
dipyridamole) Extended- Pharmaceuticals,
Release Capsules, 25 Inc., 900 Ridgebury
mg/200 mg. Rd, Ridgefield, CT
06877.
NDA 020928............. Glucagon Injection, 1 Eli Lilly and Company,
mg/vial. Lilly Corporate
Center, Indianapolis,
IN 46285.
NDA 020972............. Sustiva (efavirenz) Bristol-Myers Squibb
Capsules, 50 mg, 100 Company, P.O. Box
mg, and 200 mg. 4000, Princeton, NJ
08543-4000.
NDA 021400............. Levitra (vardenafil Bayer HealthCare
HCI) Tablets, 2.5 mg, Pharmaceuticals Inc.
5 mg, 10 mg, and 20 mg.
NDA 021449............. Hepsera (adefovir Gilead Sciences, Inc.,
dipivoxil) Tablets, 10 333 Lakeside Dr.,
mg. Foster City, CA
94404.
NDA 021623............. Synera (lidocaine and Galen Specialty Pharma
tetracaine) Patch, 70 US, LLC, 25 Fretz
mg/70 mg. Rd., Souderton, PA
18694.
NDA 022331............. Kapvay (clonidine HCl) Concordia
Extended-Release Pharmaceuticals, Inc
Tablets, 0.1 mg and C/O Cardinal Health
0.2 mg. Reg Sciences, 7400
Jenloga (clonidine HCl) West 110th St., Suite
Extended-Release 150, Overland Park,
Tablets, 0.1 mg and KS 66210.
0.2 mg.
NDA 022343............. Efavirenz, Lamivudine Aurobindo Pharma
and Tenofovir Limited C/O Aurobindo
Disoproxil Fumarate Pharma USA, Inc., 279
Tablets, 600 mg/300 mg/ Princeton-Highstown
300 mg. Rd., East Windsor, NJ
08520.
NDA 022344............. Lamivudine and Do.
Tenofovir Disoproxil
Fumarate Tablets, 300
mg/300 mg.
NDA 200179............. Staxyn (vardenafil HCl) Bayer HealthCare
Orally Disintegrating Pharmaceuticals, Inc.
Tablets, 10 mg.
NDA 200671............. Durlaza (aspirin) HESP LLC, 312
Extended-Release Farmington Ave.,
Capsules, 162.5 mg. Farmington, CT 06032.
NDA 202158............. Radiogenix System NorthStar Medical
(technetium Tc-99m Radioisotopes, LLC,
generator) For the 1800 Gateway Blvd.,
Production of Sodium Beloit, WI 53511.
Pertechnetate Tc 99m
Injection,
Intravenous,
Intravesicular, and
Ophthalmic Solution,
30-1153 millicurie/
Generator.
NDA 205004............. Bortezomib Powder for Fresenius Kabi USA,
Injection, 3.5 mg/vial. LLC, 3 Corporate Dr.,
Lake Zurich, IL
60047.
NDA 205787............. Evzio (naloxone HCl) Kaleo, Inc., 111
Solution for Virginia St., Suite
Injection, 0.4 mg/0.4 300, Richmond, VA
mL. 23219.
NDA 209862............. Evzio (naloxone HCl) Do.
Auto-Injector for
Injection, 2 mg/0.4 mL.
------------------------------------------------------------------------
Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of July 3,
2024. Approval of each entire application is withdrawn, including any
strengths and dosage forms included in the application but
inadvertently missing from table 1. Introduction or delivery for
introduction into interstate commerce of products listed in table 1
without an approved new drug application violates sections 505(a) and
301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a)
and 331(d)). Drug products that are listed in table 1 that are in
inventory on July 3, 2024 may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.
Dated: May 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12065 Filed 5-31-24; 8:45 am]
BILLING CODE 4164-01-P
