81 FR 26800 - Determination That LEUCOVORIN CALCIUM (Leucovorin Calcium) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 86 (May 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 86 (May 4, 2016)
| Page Range | 26800-26802 | |
| FR Document | 2016-10387 |
[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)] [Notices] [Pages 26800-26802] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10387] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-P-1654] Determination That LEUCOVORIN CALCIUM (Leucovorin Calcium) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. [[Page 26801]] 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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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. ---------------------------------------------------------------------------------------------------------------- Active Dosage form/ Application No. Drug name ingredient(s) Strength(s) route Applicant ---------------------------------------------------------------------------------------------------------------- NDA 008107............ LEUCOVORIN Leucovorin Equivalent to Injectable; Hospira, Inc. CALCIUM. Calcium. (EQ) 3 Injection. milligrams (mg) base/milliliter (mL); EQ 50 mg base/vial; EQ 100 mg base/ vial; EQ 350 mg base/vial. NDA 009986............ DELTASONE....... Prednisone...... 2.5 mg; 5 mg; 10 Tablet; Oral.... Pharmacia & mg; 20 mg; 50 Upjohn Co. mg. NDA 010392............ ATARAX.......... Hydroxyzine 10 mg; 25 mg; 50 Tablet; Oral.... Pfizer Inc. Hydrochloride. mg; 100 mg. NDA 016727............ PROLIXIN Fluphenazine 25 mg/mL........ Injectable; Bristol-Myers DECANOATE. Decanoate. Injection. Squibb NDA 018031............ INDERIDE-40/25 Hydrochlorothiaz Hydrochloride25 Tablet; Oral.... Wyeth and INDERIDE 80/ ide; mg; 40 mg and Pharmaceuticals 20. Propranolol. 25 mg; 80 mg. Inc. NDA 019279............ DIMETANE-DX..... Brompheniramine 2 mg/5 mL; 10 mg/ Syrup; Oral..... A.H. Robins Maleate; 5 mL; 30 mg/5 Company Dextromethorpha mL. n Hydrobromide; Pseudoephedrine Hydrochloride. NDA 050007............ VIBRAMYCIN...... Doxycycline EQ 50 mg base... Capsule; Oral... Pfizer Inc. Hyclate. ANDA 061639........... E.E.S. 200 and Erythromycin EQ 200 mg base/5 Suspension; Oral Arbor E.E.S. 400. Ethylsuccinate. mL; EQ 400 mg Pharmaceuticals base/5 mL. , LLC ANDA 062736........... BACTOCILL....... Oxacillin Sodium EQ 1 gram (g) Injectable; GlaxoSmithKline base/vial; EQ 2 Injection. g base/vial. ANDA 065012........... CEFOXITIN....... Cefoxitin Sodium EQ 1 g base/ Injectable; Fresenius Kabi vial; EQ 2 g Injection. USA base/vial. ---------------------------------------------------------------------------------------------------------------- FDA has reviewed its records and, under Sec. 314.161, and 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. [[Page 26802]] Dated: April 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-10387 Filed 5-3-16; 8:45 am] BILLING CODE 4164-01-P
![26800 Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Notices
56469, September 18, 2015, or access meet with sponsors who request to products, respectively; (3) adding
the information at: http://www.fda.gov/ meet, provided certain conditions are protocols intended to support approval
regulatoryinformation/dockets/ met, to reach agreement on the design of a biosimilar biological product; (4)
default.htm. and size of the well-controlled clinical providing greater detail about the
Docket: For access to the docket to trials intended to form the primary basis content of an SPA submission; and (5)
read background documents or the for a demonstration of effectiveness in a clarifying the process for rescinding an
electronic and written/paper comments marketing application submitted under SPA agreement. FDA seeks comments to
received, go to http:// section 505(b) of the FD&C Act or aid in finalizing this draft guidance.
www.regulations.gov and insert the section 351 of the Public Health Service This draft guidance is being issued
docket number, found in brackets in the (PHS) Act (42 U.S.C. 262). These consistent with FDA’s good guidance
heading of this document, into the provisions subsequently were amended practices regulation (21 CFR 10.115).
‘‘Search’’ box and follow the prompts in section 7002(d)(1) of the Biologics The draft guidance, when finalized, will
and/or go to the Division of Dockets Price Competition and Innovation Act of represent the current thinking of FDA
Management, 5630 Fishers Lane, Rm. 2009 to include any necessary clinical on the procedural aspects of SPA. It
1061, Rockville, MD 20852. study or studies for biosimilar biological does not establish any rights for any
Submit written requests for single product applications under section person and is not binding on FDA or the
copies of the draft guidance to the 351(k) of the PHS Act. In 2013, the public. You can use an alternative
Division of Drug Information, Center for Pandemic and All Hazards Preparedness approach if it satisfies the requirements
Drug Evaluation and Research, Food Reauthorization Act of 2013 (Pub. L. of the applicable statutes and
and Drug Administration, 10001 New 113–5) further amended the SPA regulations.
Hampshire Ave., Hillandale Building., provisions to provide for SPA II. The Paperwork Reduction Act of
4th Floor, Silver Spring, MD 20993– agreements regarding animal and 1995
0002, or Office of Communication, associated clinical trials conducted in
Outreach, and Development, Center for support of applications for products This draft guidance refers to
Biologics Evaluation and Research, developed under 21 CFR part 314 previously approved collections of
subpart I, and 21 CFR part 601 subpart information that are subject to review by
Food and Drug Administration, 10903
H (the animal rule). Such marketing the Office of Management and Budget
New Hampshire Ave., Bldg. 71, Rm.
applications include new drug (OMB) under the Paperwork Reduction
3128, Silver Spring, MD 20993–0002.
applications (NDAs), biologics license Act of 1995 (44 U.S.C. 3501–3520). The
Send one self-addressed adhesive label
applications (BLAs), and efficacy collections of information referred to in
to assist that office in processing your
supplements to approved NDAs and the guidance entitled ‘‘Special Protocol
requests. See the SUPPLEMENTARY
BLAs. Assessment’’ have been approved under
INFORMATION section for electronic
In conjunction with the Prescription OMB control number 0910–0470. The
access to the draft guidance document.
Drug User Fee Amendments of 2012 collections of information for FDA Form
FOR FURTHER INFORMATION CONTACT: 1571 have been approved under OMB
(PDUFA V), enacted as part of the Food
Amalia Himaya, Center for Drug and Drug Administration Safety and control number 0910–0014.
Evaluation and Research, Food and Innovation Act (FDASIA), and with the
Drug Administration, 10903 New III. Electronic Access
Biosimilar User Fee Act of 2012
Hampshire Ave., Bldg. 22, Rm. 6439, (BsUFA), enacted as part of FDASIA, Persons with access to the Internet
Silver Spring, MD 20993–0002, 301– FDA agreed to specific performance may obtain the document at http://
796–0700; or Stephen Ripley, Center for goals (PDUFA V goals and BsUFA goals, www.fda.gov/Drugs/
Biologics Evaluation and Research, respectively) for SPA. Per section GuidanceCompliance
Food and Drug Administration, 10903 505(b)(5)(B) of the FD&C Act, the RegulatoryInformation/Guidances/
New Hampshire Ave., Bldg. 71, Rm. PDUFA V goals, and the BsUFA goals, default.htm, http://www.fda.gov/
3128, Silver Spring, MD 20993–0002, the following protocols are eligible for BiologicsBloodVaccines/
240–402–7911. SPA: (1) Animal carcinogenicity GuidanceCompliance
SUPPLEMENTARY INFORMATION: protocols; (2) drug substance and drug RegulatoryInformation/default.htm, or
product stability protocols; (3) animal http://www.regulations.gov.
I. Background
efficacy protocols for studies intended Dated: April 28, 2016.
FDA is announcing the availability of to provide primary evidence of Leslie Kux,
a draft guidance for industry entitled effectiveness required for approval or Associate Commissioner for Policy.
‘‘Special Protocol Assessment.’’ SPA is for licensure for products developed [FR Doc. 2016–10391 Filed 5–3–16; 8:45 am]
a process by which sponsors may under the animal rule; (4) protocols for
BILLING CODE 4164–01–P
request to meet with FDA to reach clinical trials or studies intended to
agreement on the design and size of form the primary basis of an efficacy
certain trials, clinical studies, or animal claim; and (5) protocols for clinical DEPARTMENT OF HEALTH AND
trials to determine if they adequately studies necessary to prove biosimilarity HUMAN SERVICES
address scientific and regulatory and/or interchangeability.
requirements. After completing the SPA This draft guidance revises the Food and Drug Administration
review, FDA issues a letter including an guidance of the same name issued in
assessment of the protocol, agreement or May 2002. After it has been finalized, [Docket No. FDA–2013–P–1654]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
nonagreement with the proposed this guidance will replace the May 2002 Determination That LEUCOVORIN
protocol, and answers to the sponsor’s guidance. Significant changes from the CALCIUM (Leucovorin Calcium)
relevant questions. Section 119 of the 2002 version include the following: (1)
Injectable and Other Drug Products
Food and Drug Administration Clarifying which protocols are eligible
Were Not Withdrawn From Sale for
Modernization Act of 1997 amended for SPA; (2) adding animal rule efficacy
Reasons of Safety or Effectiveness
section 505(b) of the Federal Food, protocols intended to support approval
Drug, and Cosmetic Act (the FD&C Act) under part 314 subpart I, and part 601 AGENCY: Food and Drug Administration,
(21 U.S.C. 355(b)) and directed FDA to subpart H, for drugs and biological HHS.
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![26802 Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Notices
Dated: April 27, 2016. identifies you in the body of your information marked as ‘‘confidential’’
Leslie Kux, comments, that information will be will not be disclosed except in
Associate Commissioner for Policy. posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
[FR Doc. 2016–10387 Filed 5–3–16; 8:45 am] • If you want to submit a comment applicable disclosure law. For more
BILLING CODE 4164–01–P
with confidential information that you information about FDA’s posting of
do not wish to be made available to the comments to public dockets, see 80 FR
public, submit the comment as a 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND written/paper submission and in the the information at: http://www.fda.gov/
HUMAN SERVICES manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Submissions’’ and ‘‘Instructions’’). default.htm.
Food and Drug Administration Docket: For access to the docket to
Written/Paper Submissions
[Docket No. FDA–2016–P–0159] read background documents or the
Submit written/paper submissions as electronic and written/paper comments
Medical Devices; Exemption From follows: received, go to http://
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Premarket Notification: Method,
written/paper submissions): Division of docket number, found in brackets in the
Metallic Reduction, Glucose (Urinary,
Dockets Management (HFA–305), Food heading of this document, into the
Non-Quantitative) Test System in a
and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Reagent Tablet Format
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
AGENCY: Food and Drug Administration, • For written/paper comments
Management, 5630 Fishers Lane, Rm.
HHS. submitted to the Division of Dockets
1061, Rockville, MD 20852.
ACTION: Notice. Management, FDA will post your
comment, as well as any attachments, FOR FURTHER INFORMATION CONTACT: Ana
SUMMARY: The Food and Drug except for information submitted, Loloei Marsal, Center for Devices and
Administration (FDA) is announcing marked and identified, as confidential, Radiological Health (CDRH), Food and
that it has received a petition requesting if submitted as detailed in Drug Administration, 10903 New
exemption from the premarket ‘‘Instructions.’’ Hampshire Ave., Bldg. 66, Rm. 4552,
notification requirements for a method, Instructions: All submissions received Silver Spring, MD 20993–0002, 301–
metallic reduction, glucose (urinary, must include the Docket No. FDA– 796–8774,
non-quantitative) test system in a 2016–P–0159 for ‘‘Medical Devices; anahita.loloeimarsal@fda.hhs.gov.
reagent tablet format that is intended to Exemption From Premarket SUPPLEMENTARY INFORMATION:
measure glucosuria (glucose in urine). Notification: Method, Metallic
Method, metallic reduction, glucose Reduction, Glucose (Urinary, Non- I. Statutory Background
(urinary, non-quantitative) test systems Quantitative) Test System in a Reagent Under section 513 of the Federal
in a reagent tablet format are used in the Tablet Format.’’ Received comments Food, Drug, and Cosmetic Act (the
diagnosis and treatment of carbohydrate will be placed in the docket and, except FD&C Act) (21 U.S.C. 360c), FDA must
metabolism disorders including diabetes for those submitted as ‘‘Confidential classify devices into one of three
mellitus, hypoglycemia, and Submissions,’’ publicly viewable at regulatory classes: class I, class II, or
hyperglycemia. FDA is publishing this http://www.regulations.gov or at the class III. FDA classification of a device
notice to obtain comments in Division of Dockets Management is determined by the amount of
accordance with procedures established between 9 a.m. and 4 p.m., Monday regulation necessary to provide a
by the Food and Drug Administration through Friday. reasonable assurance of safety and
Modernization Act of 1997 (FDAMA). • Confidential Submissions—To effectiveness. Under the Medical Device
DATES: Submit either electronic or submit a comment with confidential Amendments of 1976 (1976
written comments by June 3, 2016. information that you do not wish to be amendments) (Pub. L. 94–295), as
ADDRESSES: You may submit comments made publicly available, submit your amended by the Safe Medical Devices
as follows: comments only as a written/paper Act of 1990 (Pub. L. 101–629), devices
submission. You should submit two are to be classified into class I (general
Electronic Submissions copies total. One copy will include the controls) if there is information showing
Submit electronic comments in the information you claim to be confidential that the general controls of the FD&C
following way: with a heading or cover note that states Act are sufficient to assure safety and
• Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS effectiveness; into class II (special
www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The controls) if general controls, by
instructions for submitting comments. Agency will review this copy, including themselves, are insufficient to provide
Comments submitted electronically, the claimed confidential information, in reasonable assurance of safety and
including attachments, to http:// its consideration of comments. The effectiveness, but there is sufficient
www.regulations.gov will be posted to second copy, which will have the information to establish special controls
the docket unchanged. Because your claimed confidential information to provide such assurance; and into
comment will be made public, you are redacted/blacked out, will be available class III (premarket approval) if there is
solely responsible for ensuring that your for public viewing and posted on insufficient information to support
comment does not include any http://www.regulations.gov. Submit classifying a device into class I or class
asabaliauskas on DSK3SPTVN1PROD with NOTICES
confidential information that you or a both copies to the Division of Dockets II and the device is a life sustaining or
third party may not wish to be posted, Management. If you do not wish your life supporting device, or is for a use
such as medical information, your or name and contact information to be which is of substantial importance in
anyone else’s Social Security number, or made publicly available, you can preventing impairment of human health
confidential business information, such provide this information on the cover or presents a potential unreasonable risk
as a manufacturing process. Please note sheet and not in the body of your of illness or injury.
that if you include your name, contact comments and you must identify this Most generic types of devices that
information, or other information that information as ‘‘confidential.’’ Any were on the market before the date of
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Document Created: 2016-05-04 01:23:05
Document Modified: 2016-05-04 01:23:05
| 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 26800 |
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