80 FR 22529 - Determination That OXYTOCIN in 5% Dextrose Injection Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 80, Issue 77 (April 22, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 77 (April 22, 2015)
| Page Range | 22529-22529 | |
| FR Document | 2015-09299 |
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)] [Notices] [Page 22529] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09299] [[Page 22529]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-P-1896] Determination That OXYTOCIN in 5% Dextrose Injection Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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 OXYTOCIN 5 United States Pharmacopeia (USP) Units in Dextrose 5% (oxytocin), injectable, injection, 5 USP Units in 500 milliliters (mL), (1 USP Unit/100 mL); OXYTOCIN 10 USP Units in Dextrose 5% (oxytocin), injectable, injection, 10 USP Units in 500 mL, (2 USP Units/100 mL); OXYTOCIN 10 USP Units in Dextrose 5% (oxytocin), injectable, injection, 10 USP Units in 1000 mL, (1 USP Unit/100 mL); and OXYTOCIN 20 USP Units in Dextrose 5% (oxytocin), injectable, injection, 20 USP Units in 1000 mL, (2 USP Units/100 mL), (hereinafter ``these oxytocin drug products'') were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve an abbreviated new drug application (ANDA) for these oxytocin drug products, if all other legal and regulatory requirements are met. 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 (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. These oxytocin drug products are the subject of NDA 019-185, held by Abbott Laboratories, and initially approved on March 29, 1985. These oxytocin drug products are indicated for the initiation or improvement of uterine contractions. In a December 26, 1995, letter, Abbott Laboratories notified FDA that these oxytocin drug products were being discontinued and requested withdrawal of NDA 019-185. In the Federal Register of March 27, 1996 (61 FR 13506), FDA announced that it was withdrawing approval of NDA 019-185, effective April 26, 1996. FDA has moved these oxytocin drug products to the ``Discontinued Drug Product List'' section of the Orange Book. TechReg Services, Inc. (TechReg), submitted a citizen petition dated November 12, 2014 (Docket No. FDA-2014-P-1896), under 21 CFR 10.30, requesting that the Agency determine whether Oxytocin in Dextrose 5%, injection, available as strengths 5, 10, and 20 units under Abbott NDA 019-185, were withdrawn from sale for reasons of safety or effectiveness. Although the citizen petition did not specify the concentrations of the three strengths associated with NDA 019-185, we have considered whether any of these oxytocin drug products approved under NDA 019-185 were withdrawn for safety or effectiveness reasons. After considering the citizen petition and reviewing Agency records, and based on the information we have at this time, FDA has determined under Sec. 314.161 that these oxytocin drug products were not withdrawn for reasons of safety or effectiveness. TechReg has identified no data or other information suggesting that these oxytocin drug products were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of these oxytocin drug products from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that these oxytocin drug products were withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list these oxytocin drug products in the ``Discontinued Drug Product List'' section of the Orange Book. The ``Discontinued Drug Product List'' delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to these oxytocin drug products may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. FDA has determined that labeling for these oxytocin drug products should be revised to meet current standards and will advise ANDA applicants how to submit such labeling. Dated: April 16, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-09299 Filed 4-21-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22529
DEPARTMENT OF HEALTH AND Food, Drug, and Cosmetic Act (21 U.S.C. TechReg has identified no data or other
HUMAN SERVICES 355(j)(7)), which requires FDA to information suggesting that these
publish a list of all approved drugs. oxytocin drug products were withdrawn
Food and Drug Administration FDA publishes this list as part of the for reasons of safety or effectiveness. We
‘‘Approved Drug Products With have carefully reviewed our files for
[Docket No. FDA–2014–P–1896]
Therapeutic Equivalence Evaluations,’’ records concerning the withdrawal of
Determination That OXYTOCIN in 5% which is known generally as the these oxytocin drug products from sale.
Dextrose Injection Products Were Not ‘‘Orange Book.’’ Under FDA regulations, We have also independently evaluated
Withdrawn From Sale for Reasons of drugs are removed from the list if the relevant literature and data for possible
Safety or Effectiveness Agency withdraws or suspends postmarketing adverse events. We have
approval of the drug’s NDA or ANDA found no information that would
AGENCY: Food and Drug Administration, for reasons of safety or effectiveness or indicate that these oxytocin drug
HHS. if FDA determines that the listed drug products were withdrawn from sale for
ACTION: Notice. was withdrawn from sale for reasons of reasons of safety or effectiveness.
safety or effectiveness (21 CFR 314.162). Accordingly, the Agency will
SUMMARY: The Food and Drug A person may petition the Agency to continue to list these oxytocin drug
Administration (FDA or Agency) has determine, or the Agency may products in the ‘‘Discontinued Drug
determined that OXYTOCIN 5 United determine on its own initiative, whether Product List’’ section of the Orange
States Pharmacopeia (USP) Units in a listed drug was withdrawn from sale Book. The ‘‘Discontinued Drug Product
Dextrose 5% (oxytocin), injectable, for reasons of safety or effectiveness. List’’ delineates, among other items,
injection, 5 USP Units in 500 milliliters This determination may be made at any drug products that have been
(mL), (1 USP Unit/100 mL); OXYTOCIN time after the drug has been withdrawn discontinued from marketing for reasons
10 USP Units in Dextrose 5% from sale, but must be made prior to other than safety or effectiveness.
(oxytocin), injectable, injection, 10 USP approving an ANDA that refers to the ANDAs that refer to these oxytocin drug
Units in 500 mL, (2 USP Units/100 mL); listed drug (§ 314.161 (21 CFR 314.161)). products may be approved by the
OXYTOCIN 10 USP Units in Dextrose FDA may not approve an ANDA that Agency as long as they meet all other
5% (oxytocin), injectable, injection, 10 does not refer to a listed drug. legal and regulatory requirements for
USP Units in 1000 mL, (1 USP Unit/100 These oxytocin drug products are the the approval of ANDAs. FDA has
mL); and OXYTOCIN 20 USP Units in subject of NDA 019–185, held by Abbott determined that labeling for these
Dextrose 5% (oxytocin), injectable, Laboratories, and initially approved on oxytocin drug products should be
injection, 20 USP Units in 1000 mL, (2 March 29, 1985. These oxytocin drug revised to meet current standards and
USP Units/100 mL), (hereinafter ‘‘these products are indicated for the initiation will advise ANDA applicants how to
oxytocin drug products’’) were not or improvement of uterine contractions.
submit such labeling.
withdrawn from sale for reasons of In a December 26, 1995, letter, Abbott
Laboratories notified FDA that these Dated: April 16, 2015.
safety or effectiveness. This
determination will allow FDA to oxytocin drug products were being Leslie Kux,
approve an abbreviated new drug discontinued and requested withdrawal Associate Commissioner for Policy.
application (ANDA) for these oxytocin of NDA 019–185. In the Federal [FR Doc. 2015–09299 Filed 4–21–15; 8:45 am]
drug products, if all other legal and Register of March 27, 1996 (61 FR BILLING CODE 4164–01–P
regulatory requirements are met. 13506), FDA announced that it was
withdrawing approval of NDA 019–185,
FOR FURTHER INFORMATION CONTACT:
effective April 26, 1996. FDA has moved DEPARTMENT OF HEALTH AND
Robin Fastenau, Center for Drug these oxytocin drug products to the HUMAN SERVICES
Evaluation and Research, Food and ‘‘Discontinued Drug Product List’’
Drug Administration, 10903 New section of the Orange Book. Food and Drug Administration
Hampshire Ave., Bldg. 51, Rm. 6236, TechReg Services, Inc. (TechReg),
Silver Spring, MD 20993–0002, 240– [Docket No. FDA–2015–D–1163]
submitted a citizen petition dated
402–4510. November 12, 2014 (Docket No. FDA– Providing Regulatory Submissions in
SUPPLEMENTARY INFORMATION: In 1984, 2014–P–1896), under 21 CFR 10.30, Electronic and Non-Electronic
Congress enacted the Drug Price requesting that the Agency determine Format—Promotional Labeling and
Competition and Patent Term whether Oxytocin in Dextrose 5%, Advertising Materials for Human
Restoration Act of 1984 (Pub. L. 98–417) injection, available as strengths 5, 10, Prescription Drugs, Draft Guidance for
(the 1984 amendments), which and 20 units under Abbott NDA 019– Industry; Availability
authorized the approval of duplicate 185, were withdrawn from sale for
versions of drug products under an reasons of safety or effectiveness. AGENCY: Food and Drug Administration,
ANDA procedure. ANDA applicants Although the citizen petition did not HHS.
must, with certain exceptions, show that specify the concentrations of the three ACTION: Notice.
the drug for which they are seeking strengths associated with NDA 019–185,
approval contains the same active we have considered whether any of SUMMARY: The Food and Drug
ingredient in the same strength and these oxytocin drug products approved Administration (FDA) is announcing the
dosage form as the ‘‘listed drug,’’ which under NDA 019–185 were withdrawn availability of a draft guidance for
asabaliauskas on DSK5VPTVN1PROD with NOTICES
is a version of the drug that was for safety or effectiveness reasons. industry entitled ‘‘Providing Regulatory
previously approved. ANDA applicants After considering the citizen petition Submissions in Electronic and Non-
do not have to repeat the extensive and reviewing Agency records, and Electronic Format—Promotional
clinical testing otherwise necessary to based on the information we have at this Labeling and Advertising Materials for
gain approval of a new drug application time, FDA has determined under Human Prescription Drugs.’’ This draft
(NDA). § 314.161 that these oxytocin drug guidance explains how manufacturers,
The 1984 amendments include what products were not withdrawn for packers, and distributors (firms) that
is now section 505(j)(7) of the Federal reasons of safety or effectiveness. may either be the applicant or acting on
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Document Created: 2015-12-16 08:27:26
Document Modified: 2015-12-16 08:27:26
| 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 22529 |
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