Determination That THORAZINE (Chlorpromazine Hydrochloride) Tablets and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 3430-3431 [2016-01097]

Download as PDF 3430 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices and statistical analyses of target animal safety (TAS) data submitted to CVM as part of a study report to support approval of a new animal drug. These recommendations apply to TAS data generated from both TAS and field effectiveness studies conducted in companion animals (e.g., dogs, cats, and horses) and food animals (e.g., swine, ruminants, fish, and poultry). II. Significance of Guidance This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Target Animal Safety Data Presentation and Statistical Analysis. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: January 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–01098 Filed 1–20–16; 8:45 am] BILLING CODE 4164–01–P 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FDA–2016–N–0119] Determination That THORAZINE (Chlorpromazine Hydrochloride) Tablets and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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, Stacy.Kane@fda.hhs.gov. 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 SUMMARY: 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 § 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 NDA 009149 ...... THORAZINE (chlorpromazine hydrochloride (HCl)) Tablet; Oral, 10 milligrams (mg); 25 mg; 50 mg; 100 mg; 200 mg. CYTARABINE (cytarabine) Injectable; Injection, 100 mg/vial; 500 mg/vial; 1 gram (g)/vial; 2 g/vial. CAPOTEN (captopril) Tablet; Oral, 37.5 mg; 75 mg; 150 mg .................................................. INOMAX (nitric oxide) Gas; Inhalation, 100 parts per million ................................................... GLUCOVANCE (glyburide; metformin HCl) Tablet; Oral, 1.25 mg; 250 mg ............................ BLENOXANE (bleomycin sulfate) Injectable; Injection, EQ 15 units base/vial; EQ 30 units base/vial. STATICIN (erythromycin) Solution; Topical, 1.5% .................................................................... Teva Pharmaceuticals USA, Inc. Par Pharmaceutical, Inc. Ino Therapeutics, Inc. Bristol-Myers Squibb Bristol-Myers Squibb VANTIN (cefpodoxime proxetil) For Suspension; Oral, EQ 50 mg base/5 mL; EQ 100 mg base/5 mL. SUCLEAR (magnesium sulfate, polyethylene glycol 3350, potassium chloride, potassium 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. CLEOCIN (clindamycin palmitate HCl) For Solution; Oral, EQ 75 mg base/5 mL ................... Braintree Laboratories, Inc. NDA 016793 ...... asabaliauskas on DSK9F6TC42PROD with NOTICES NDA NDA NDA NDA 018343 020845 021178 050443 ...... ...... ...... ...... NDA 050526 ...... NDA 050675 ...... NDA 203595 ...... ANDA 061827 .... VerDate Sep<11>2014 18:26 Jan 20, 2016 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Applicant Sfmt 4703 E:\FR\FM\21JAN1.SGM 21JAN1 GlaxoSmithKline. Westwood-Squibb Pharmaceuticals, Inc. Pharmacia & Upjohn Co. Pharmacia & Upjohn Co. 3431 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices Application No. Drug ANDA 062436 .... T–STAT (erythromycin) Solution; Topical, 2% .......................................................................... ANDA 080439 .... CHLORPROMAZINE HCl (chlorpromazine HCl) Tablet; Oral, 10 mg; 25 mg; 50 mg; 100 mg; 200 mg. FDA has reviewed its records and, under § 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. asabaliauskas on DSK9F6TC42PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. VerDate Sep<11>2014 18:26 Jan 20, 2016 Jkt 238001 Applicant Date and Time: The meeting will be held on February 16, 2016 from 1 p.m. to 5 p.m. Location: FDA White Oak Conference Center, rm 1503. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. Contact Person: Janie Kim or Rosanna Harvey, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993–0002, 301–796–9016 or 240– 402–8072, janie.kim@fda.hhs.gov or Rosanna.Harvey@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On February 16, 2016, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Tumor Vaccines and Biotechnology Branch and the Cellular and Tissue Therapy Branch of the Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene Therapy, Center for Biologics Evaluation and Research, FDA. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Westwood-Squibb Pharmaceuticals, Inc. Sandoz Inc. AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On February 16, 2016, from 1:00 p.m. to 3:55 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 1, 2016. Oral presentations from the public will be scheduled between approximately 2:55 p.m. to 3:55 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 22, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 25, 2016. Closed Committee Deliberations: On February 16, 2016, from 3:55 p.m. to 5:00 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of intramural research programs and make recommendations regarding personnel staffing decisions. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Janie Kim at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ E:\FR\FM\21JAN1.SGM 21JAN1

Agencies

[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3430-3431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01097]


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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, 
Stacy.Kane@fda.hhs.gov.

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

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