81 FR 3430 - Determination That THORAZINE (Chlorpromazine Hydrochloride) Tablets and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 13 (January 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 13 (January 21, 2016)
| Page Range | 3430-3431 | |
| FR Document | 2016-01097 |
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)] [Notices] [Pages 3430-3431] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01097] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0119] Determination That THORAZINE (Chlorpromazine Hydrochloride) Tablets and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363, [email protected]. 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 approved 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 (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 generally known as the ``Orange Book''. Under FDA regulations, a drug is 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). Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table in this document are no longer being marketed. ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ NDA 009149........... THORAZINE (chlorpromazine GlaxoSmithKline. hydrochloride (HCl)) Tablet; Oral, 10 milligrams (mg); 25 mg; 50 mg; 100 mg; 200 mg. NDA 016793........... CYTARABINE (cytarabine) Teva Injectable; Injection, 100 mg/ Pharmaceuticals vial; 500 mg/vial; 1 gram (g)/ USA, Inc. vial; 2 g/vial. NDA 018343........... CAPOTEN (captopril) Tablet; Par Oral, 37.5 mg; 75 mg; 150 mg. Pharmaceutical, Inc. NDA 020845........... INOMAX (nitric oxide) Gas; Ino Inhalation, 100 parts per Therapeutics, million. Inc. NDA 021178........... GLUCOVANCE (glyburide; Bristol-Myers metformin HCl) Tablet; Oral, Squibb 1.25 mg; 250 mg. NDA 050443........... BLENOXANE (bleomycin sulfate) Bristol-Myers Injectable; Injection, EQ 15 Squibb units base/vial; EQ 30 units base/vial. NDA 050526........... STATICIN (erythromycin) Westwood-Squibb Solution; Topical, 1.5%. Pharmaceuticals , Inc. NDA 050675........... VANTIN (cefpodoxime proxetil) Pharmacia & For Suspension; Oral, EQ 50 mg Upjohn Co. base/5 mL; EQ 100 mg base/5 mL. NDA 203595........... SUCLEAR (magnesium sulfate, Braintree polyethylene glycol 3350, Laboratories, potassium chloride, potassium Inc. sulfate, sodium bicarbonate, sodium chloride, sodium sulfate) Solution; Oral, 1.6 g, 210 g, 0.74 g, 3.13 g, 2.86 g, 5.6 g, 17.5 g. ANDA 061827.......... CLEOCIN (clindamycin palmitate Pharmacia & HCl) For Solution; Oral, EQ 75 Upjohn Co. mg base/5 mL. [[Page 3431]] ANDA 062436.......... T-STAT (erythromycin) Solution; Westwood-Squibb Topical, 2%. Pharmaceuticals , Inc. ANDA 080439.......... CHLORPROMAZINE HCl Sandoz Inc. (chlorpromazine HCl) Tablet; Oral, 10 mg; 25 mg; 50 mg; 100 mg; 200 mg. ------------------------------------------------------------------------ FDA has reviewed its records and, under Sec. 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the ``Discontinued Drug Product List'' section of the Orange Book. The ``Discontinued Drug Product List'' identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: January 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-01097 Filed 1-20-16; 8:45 am] BILLING CODE 4164-01-P
![3430 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
and statistical analyses of target animal DEPARTMENT OF HEALTH AND the same strength and dosage form as
safety (TAS) data submitted to CVM as HUMAN SERVICES the ‘‘listed drug,’’ which is a version of
part of a study report to support the drug that was previously approved.
approval of a new animal drug. These Food and Drug Administration ANDA applicants do not have to repeat
recommendations apply to TAS data [Docket No. FDA–2016–N–0119] the extensive clinical testing otherwise
generated from both TAS and field necessary to gain approval of a new
effectiveness studies conducted in Determination That THORAZINE drug application (NDA).
companion animals (e.g., dogs, cats, and (Chlorpromazine Hydrochloride)
horses) and food animals (e.g., swine, The 1984 amendments include what
Tablets and Other Drug Products Were
ruminants, fish, and poultry). is now section 505(j)(7) of the Federal
Not Withdrawn From Sale for Reasons
Food, Drug, and Cosmetic Act (21 U.S.C.
II. Significance of Guidance of Safety or Effectiveness
355(j)(7)), which requires FDA to
This level 1 guidance is being issued AGENCY: Food and Drug Administration, publish a list of all approved drugs.
consistent with FDA’s good guidance HHS. FDA publishes this list as part of the
practices regulation (21 CFR 10.115). ACTION: Notice. ‘‘Approved Drug Products With
The guidance represents the current Therapeutic Equivalence Evaluations,’’
thinking of FDA on Target Animal SUMMARY: The Food and Drug
which is generally known as the
Safety Data Presentation and Statistical Administration (FDA or Agency) has
‘‘Orange Book’’. Under FDA regulations,
Analysis. It does not establish any rights determined that the drug products listed
in this document were not withdrawn a drug is removed from the list if the
for any person and is not binding on Agency withdraws or suspends
FDA or the public. You can use an from sale for reasons of safety or
effectiveness. This determination means approval of the drug’s NDA or ANDA
alternative approach if it satisfies the
that FDA will not begin procedures to for reasons of safety or effectiveness, or
requirements of the applicable statutes
withdraw approval of abbreviated new if FDA determines that the listed drug
and regulations.
drug applications (ANDAs) that refer to was withdrawn from sale for reasons of
III. Paperwork Reduction Act of 1995 these drug products, and it will allow safety or effectiveness (21 CFR 314.162).
This guidance refers to previously FDA to continue to approve ANDAs that Under § 314.161(a) (21 CFR
approved collections of information refer to the products as long as they 314.161(a)), the Agency must determine
found in FDA regulations. These meet relevant legal and regulatory whether a listed drug was withdrawn
collections of information are subject to requirements. from sale for reasons of safety or
review by the Office of Management and FOR FURTHER INFORMATION CONTACT: effectiveness: (1) Before an ANDA that
Budget (OMB) under the Paperwork Stacy Kane, Center for Drug Evaluation refers to that listed drug may be
Reduction Act of 1995 (44 U.S.C. 3501– and Research, Food and Drug approved, (2) whenever a listed drug is
3520). The collections of information in Administration, 10903 New Hampshire voluntarily withdrawn from sale and
21 CFR part 514 have been approved Ave., Bldg. 51, Rm. 6207, Silver Spring, ANDAs that refer to the listed drug have
under OMB control number 0910–0032. MD 20993–0002, 301–796–8363, been approved, and (3) when a person
IV. Electronic Access Stacy.Kane@fda.hhs.gov. petitions for such a determination under
SUPPLEMENTARY INFORMATION: In 1984, 21 CFR 10.25(a) and 10.30. Section
Persons with access to the Internet
may obtain the draft guidance at either Congress enacted the Drug Price 314.161(d) provides that if FDA
http://www.fda.gov/AnimalVeterinary/ Competition and Patent Term determines that a listed drug was
GuidanceComplianceEnforcement/ Restoration Act of 1984 (Pub. L. 98–417) withdrawn from sale for safety or
GuidanceforIndustry/default.htm or (the 1984 amendments), which effectiveness reasons, the Agency will
http://www.regulations.gov. authorized the approval of duplicate initiate proceedings that could result in
versions of drug products approved the withdrawal of approval of the
Dated: January 13, 2016. under an ANDA procedure. ANDA
Leslie Kux, ANDAs that refer to the listed drug.
applicants must, with certain
Associate Commissioner for Policy. exceptions, show that the drug for FDA has become aware that the drug
[FR Doc. 2016–01098 Filed 1–20–16; 8:45 am] which they are seeking approval products listed in the table in this
BILLING CODE 4164–01–P contains the same active ingredient in document are no longer being marketed.
Application No. Drug Applicant
NDA 009149 ...... THORAZINE (chlorpromazine hydrochloride (HCl)) Tablet; Oral, 10 milligrams (mg); 25 mg; GlaxoSmithKline.
50 mg; 100 mg; 200 mg.
NDA 016793 ...... CYTARABINE (cytarabine) Injectable; Injection, 100 mg/vial; 500 mg/vial; 1 gram (g)/vial; 2 Teva Pharmaceuticals USA,
g/vial. Inc.
NDA 018343 ...... CAPOTEN (captopril) Tablet; Oral, 37.5 mg; 75 mg; 150 mg .................................................. Par Pharmaceutical, Inc.
NDA 020845 ...... INOMAX (nitric oxide) Gas; Inhalation, 100 parts per million ................................................... Ino Therapeutics, Inc.
NDA 021178 ...... GLUCOVANCE (glyburide; metformin HCl) Tablet; Oral, 1.25 mg; 250 mg ............................ Bristol-Myers Squibb
NDA 050443 ...... BLENOXANE (bleomycin sulfate) Injectable; Injection, EQ 15 units base/vial; EQ 30 units Bristol-Myers Squibb
base/vial.
asabaliauskas on DSK9F6TC42PROD with NOTICES
NDA 050526 ...... STATICIN (erythromycin) Solution; Topical, 1.5% .................................................................... Westwood-Squibb Pharma-
ceuticals, Inc.
NDA 050675 ...... VANTIN (cefpodoxime proxetil) For Suspension; Oral, EQ 50 mg base/5 mL; EQ 100 mg Pharmacia & Upjohn Co.
base/5 mL.
NDA 203595 ...... SUCLEAR (magnesium sulfate, polyethylene glycol 3350, potassium chloride, potassium Braintree Laboratories, Inc.
sulfate, sodium bicarbonate, sodium chloride, sodium sulfate) Solution; Oral, 1.6 g, 210 g,
0.74 g, 3.13 g, 2.86 g, 5.6 g, 17.5 g.
ANDA 061827 .... CLEOCIN (clindamycin palmitate HCl) For Solution; Oral, EQ 75 mg base/5 mL ................... Pharmacia & Upjohn Co.
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![Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices 3431
Application No. Drug Applicant
ANDA 062436 .... T–STAT (erythromycin) Solution; Topical, 2% .......................................................................... Westwood-Squibb Pharma-
ceuticals, Inc.
ANDA 080439 .... CHLORPROMAZINE HCl (chlorpromazine HCl) Tablet; Oral, 10 mg; 25 mg; 50 mg; 100 Sandoz Inc.
mg; 200 mg.
FDA has reviewed its records and, Date and Time: The meeting will be AdvisoryCommittees/Calendar/
under § 314.161, has determined that held on February 16, 2016 from 1 p.m. default.htm. Scroll down to the
the drug products listed in this to 5 p.m. appropriate advisory committee meeting
document were not withdrawn from Location: FDA White Oak Conference link.
sale for reasons of safety or Center, rm 1503. Answers to commonly Procedure: On February 16, 2016,
effectiveness. Accordingly, the Agency asked questions including information from 1:00 p.m. to 3:55 p.m., the meeting
will continue to list the drug products regarding special accommodations due is open to the public. Interested persons
listed in this document in the to a disability, visitor parking, and may present data, information, or views,
‘‘Discontinued Drug Product List’’ transportation may be accessed at: orally or in writing, on issues pending
section of the Orange Book. The http://www.fda.gov/ before the committee. Written
‘‘Discontinued Drug Product List’’ AdvisoryCommittees/ submissions may be made to the contact
identifies, among other items, drug AboutAdvisoryCommittees/ person on or before February 1, 2016.
products that have been discontinued ucm408555.htm. Oral presentations from the public will
from marketing for reasons other than Contact Person: Janie Kim or Rosanna be scheduled between approximately
safety or effectiveness. Harvey, Center for Biologics Evaluation 2:55 p.m. to 3:55 p.m. Those individuals
Approved ANDAs that refer to the and Research, Food and Drug interested in making formal oral
NDAs and ANDAs listed in this Administration, 10903 New Hampshire presentations should notify the contact
document are unaffected by the Ave., Bldg. 71, Silver Spring, MD person and submit a brief statement of
discontinued marketing of the products 20993–0002, 301–796–9016 or 240– the general nature of the evidence or
subject to those NDAs and ANDAs. 402–8072, janie.kim@fda.hhs.gov or arguments they wish to present, the
Additional ANDAs that refer to these Rosanna.Harvey@fda.hhs.gov, or FDA names and addresses of proposed
products may also be approved by the Advisory Committee Information Line, participants, and an indication of the
Agency if they comply with relevant 1–800–741–8138 (301–443–0572 in the approximate time requested to make
legal and regulatory requirements. If Washington, DC area). A notice in the their presentation on or before January
FDA determines that labeling for these Federal Register about last minute 22, 2016. Time allotted for each
drug products should be revised to meet modifications that impact a previously presentation may be limited. If the
current standards, the Agency will announced advisory committee meeting number of registrants requesting to
advise ANDA applicants to submit such cannot always be published quickly speak is greater than can be reasonably
labeling. enough to provide timely notice. accommodated during the scheduled
Therefore, you should always check the open public hearing session, FDA may
Dated: January 14, 2016.
Agency’s Web site at http:// conduct a lottery to determine the
Leslie Kux,
www.fda.gov/AdvisoryCommittees/ speakers for the scheduled open public
Associate Commissioner for Policy. default.htm and scroll down to the hearing session. The contact person will
[FR Doc. 2016–01097 Filed 1–20–16; 8:45 am] appropriate advisory committee meeting notify interested persons regarding their
BILLING CODE 4164–01–P link, or call the advisory committee request to speak by January 25, 2016.
information line to learn about possible Closed Committee Deliberations: On
modifications before coming to the February 16, 2016, from 3:55 p.m. to
DEPARTMENT OF HEALTH AND meeting. 5:00 p.m., the meeting will be closed to
HUMAN SERVICES Agenda: On February 16, 2016, the permit discussion where disclosure
committee will meet by teleconference. would constitute a clearly unwarranted
Food and Drug Administration In open session, the committee will hear invasion of personal privacy (5 U.S.C.
[Docket No. FDA–2016–N–0001] updates of research programs in the 552b(c)(6)). The committee will discuss
Tumor Vaccines and Biotechnology reports of intramural research programs
Cellular, Tissue and Gene Therapies Branch and the Cellular and Tissue and make recommendations regarding
Advisory Committee; Notice of Meeting Therapy Branch of the Division of personnel staffing decisions.
AGENCY: Food and Drug Administration, Cellular and Gene Therapies, Office of Persons attending FDA’s advisory
HHS. Cellular, Tissue and Gene Therapy, committee meetings are advised that the
Center for Biologics Evaluation and Agency is not responsible for providing
ACTION: Notice.
Research, FDA. access to electrical outlets.
This notice announces a forthcoming FDA intends to make background FDA welcomes the attendance of the
meeting of a public advisory committee material available to the public no later public at its advisory committee
of the Food and Drug Administration than 2 business days before the meeting. meetings and will make every effort to
(FDA). At least one portion of the If FDA is unable to post the background accommodate persons with disabilities.
asabaliauskas on DSK9F6TC42PROD with NOTICES
meeting will be closed to the public. material on its Web site prior to the If you require accommodations due to a
Name of Committee: Cellular, Tissue meeting, the background material will disability, please contact Janie Kim at
and Gene Therapies Advisory be made publicly available at the least 7 days in advance of the meeting.
Committee. location of the advisory committee FDA is committed to the orderly
General Function of the Committee: meeting, and the background material conduct of its advisory committee
To provide advice and will be posted on FDA’s Web site after meetings. Please visit our Web site at
recommendations to the Agency on the meeting. Background material is http://www.fda.gov/
FDA’s regulatory issues. available at http://www.fda.gov/ AdvisoryCommittees/
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Document Created: 2018-02-02 12:34:01
Document Modified: 2018-02-02 12:34:01
| 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 | Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363, [email protected] | |
| FR Citation | 81 FR 3430 |
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