83_FR_43064 83 FR 42899 - Determination That PLASMA-LYTE M AND DEXTROSE 5% and PLASMA LYTE 148 AND DEXTROSE 5% Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

83 FR 42899 - Determination That PLASMA-LYTE M AND DEXTROSE 5% and PLASMA LYTE 148 AND DEXTROSE 5% Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 165 (August 24, 2018)

Page Range42899-42900
FR Document2018-18311

The Food and Drug Administration (FDA or Agency) has determined that PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 milligrams (mg)/100 milliliters (mL); dextrose, 5 grams (g)/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL; sodium chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) and PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL; sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium gluconate, 502 mg/100 mL) were not withdrawn from sale for reasons of safety or effectiveness.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 these products as long as they meet relevant legal and regulatory requirements.

Federal Register, Volume 83 Issue 165 (Friday, August 24, 2018) 
[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42899-42900]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18311]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-P-0964 and FDA-2018-P-0967]


Determination That PLASMA-LYTE M AND DEXTROSE 5% and PLASMA LYTE 
148 AND DEXTROSE 5% Were Not Withdrawn From Sale for Reasons of Safety 
or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 
milligrams (mg)/100 milliliters (mL); dextrose, 5 grams (g)/100 mL; 
magnesium chloride, 30 mg/100 mL; potassium chloride, 119 mg/100 mL; 
sodium acetate, 161 mg/100 mL; sodium chloride, 94 mg/100 mL; sodium 
lactate, 138 mg/100 mL) and PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 
5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37 
mg/100 mL; sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 
mL; sodium gluconate, 502 mg/100 mL) 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 these products as 
long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Heather A. Dorsey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-3601.

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.
    PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 mg/100 mL; 
dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium 
chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL; sodium 
chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) is the subject 
of NDA 017390, held by Baxter Healthcare Corp., and initially approved 
on February 1, 1979. PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100 
mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL; 
sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium 
gluconate, 502 mg/100 mL) is the subject of NDA 017451, held by Baxter 
Healthcare Corp., and initially approved on February 2, 1979. PLASMA 
LYTE M AND DEXTROSE 5% is indicated as a source of water, electrolytes, 
and calories or as an alkalinizing agent. PLASMA LYTE 148 AND DEXTROSE 
5% is indicated as a source of water, electrolytes, and calories, or as 
an alkalinizing agent.
    PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 mg/100 mL; 
dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium 
chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL; sodium 
chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) and PLASMA LYTE 
148 AND DEXTROSE

[[Page 42900]]

5% (dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium 
chloride, 37 mg/100 mL; sodium acetate, 368 mg/100 mL; sodium chloride, 
526 mg/100 mL; sodium gluconate, 502 mg/100 mL) are currently listed in 
the ``Discontinued Drug Product List'' section of the Orange Book. In 
the Federal Register of October 13, 2015 (80 FR 61426), FDA announced 
that it was withdrawing approval of NDAs 017390 and 017451, effective 
November 12, 2015.
    Fresenius Kabi USA, LLC, submitted two citizen petitions dated 
March 2, 2018 (Docket No. FDA-2018-P-0964), and March 5, 2018 (Docket 
No. FDA-2018-P-0967), under 21 CFR 10.30, requesting that the Agency 
determine whether PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 
mg/100 mL; dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; 
potassium chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL; 
sodium chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) and 
PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100 mL; magnesium 
chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL; sodium 
acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium 
gluconate, 502 mg/100 mL) were withdrawn from sale for reasons of 
safety or effectiveness.
    After considering the citizen petitions and reviewing Agency 
records and based on the information we have at this time, FDA has 
determined under Sec.  314.161 that PLASMA-LYTE M AND DEXTROSE 5% 
(calcium chloride, 37 mg/100 mL; dextrose, 5 g/100 mL; magnesium 
chloride, 30 mg/100 mL; potassium chloride, 119 mg/100 mL; sodium 
acetate, 161 mg/100 mL; sodium chloride, 94 mg/100 mL; sodium lactate, 
138 mg/100 mL) and PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100 
mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL; 
sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium 
gluconate, 502 mg/100 mL) were not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that these drug products were withdrawn for 
reasons of safety or effectiveness.
    We have carefully reviewed our files for records concerning the 
withdrawal of PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 mg/
100 mL; dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; 
potassium chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL; 
sodium chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) and 
PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100 mL; magnesium 
chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL; sodium 
acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium 
gluconate, 502 mg/100 mL) from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events. We have reviewed the available evidence and determined 
that these drug products were not withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list PLASMA-LYTE M AND 
DEXTROSE 5% (calcium chloride, 37 mg/100 mL; dextrose, 5 g/100 mL; 
magnesium chloride, 30 mg/100 mL; potassium chloride, 119 mg/100 mL; 
sodium acetate, 161 mg/100 mL; sodium chloride, 94 mg/100 mL; sodium 
lactate, 138 mg/100 mL) and PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 
5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37 
mg/100 mL; sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 
mL; sodium gluconate, 502 mg/100 mL) 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 drug products may be approved 
by the Agency as long as they meet all other legal and regulatory 
requirements for the approval of ANDAs. 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: August 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18311 Filed 8-23-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 42899 25. Osmanov, A. and D.W. Denning, ‘‘Burden DEPARTMENT OF HEALTH AND do not have to repeat the extensive of Serious Fungal Infections in Ukraine,’’ HUMAN SERVICES clinical testing otherwise necessary to Mycoses, 58(Suppl 5): 94–100, October gain approval of a new drug application 2015. Food and Drug Administration (NDA). 26. Morrow, B.M., N.Y. Hsaio, M. Zampoli, et al., ‘‘Pneumocystis Pneumonia in The 1984 amendments include what [Docket Nos. FDA–2018–P–0964 and FDA– South African Children with and 2018–P–0967] is now section 505(j)(7) of the Federal Without Human Immunodeficiency Food, Drug, and Cosmetic Act (21 U.S.C. Virus Infection in the Era of Highly Determination That PLASMA–LYTE M 355(j)(7)), which requires FDA to Active Antiretroviral Therapy,’’ The AND DEXTROSE 5% and PLASMA publish a list of all approved drugs. Pediatric Infectious Disease Journal, LYTE 148 AND DEXTROSE 5% Were FDA publishes this list as part of the 29(6):535–539, June 2010. ‘‘Approved Drug Products With 27. Stansell, J.D., D.H. Osmond, E. Not Withdrawn From Sale for Reasons of Safety or Effectiveness Therapeutic Equivalence Evaluations,’’ Charlebois, E., et al., ‘‘Predictors of Pneumocystis carinii Pneumonia in HIV- which is known generally as the Infected Persons. Pulmonary AGENCY: Food and Drug Administration, ‘‘Orange Book.’’ Under FDA regulations, Complications of HIV Infection Study HHS. drugs are removed from the list if the Group,’’ American Journal of Respiratory ACTION: Notice. Agency withdraws or suspends and Critical Care Medicine, 155(1):60– approval of the drug’s NDA or ANDA 66, January 1997. SUMMARY: The Food and Drug for reasons of safety or effectiveness or 28. Wasserman, S., M.E. Engel, M. Administration (FDA or Agency) has if FDA determines that the listed drug Mendelson, ‘‘Burden of Pneumocystis determined that PLASMA–LYTE M was withdrawn from sale for reasons of Pneumonia in HIV-Infected Adults in AND DEXTROSE 5% (calcium chloride, Sub-Saharan Africa: Protocol for a safety or effectiveness (21 CFR 314.162). Systematic Review,’’ Systematic 37 milligrams (mg)/100 milliliters (mL); A person may petition the Agency to Reviews, 2:112, December 12, 2013. dextrose, 5 grams (g)/100 mL; determine, or the Agency may 29. Fisk, D.T., S. Meshnick, S., and P.H. magnesium chloride, 30 mg/100 mL; determine on its own initiative, whether Kazanjian, ‘‘Pneumocystis carinii potassium chloride, 119 mg/100 mL; a listed drug was withdrawn from sale Pneumonia in Patients in the Developing sodium acetate, 161 mg/100 mL; sodium for reasons of safety or effectiveness. World Who Have Acquired chloride, 94 mg/100 mL; sodium lactate, This determination may be made at any Immunodeficiency Syndrome,’’ Clinical 138 mg/100 mL) and PLASMA LYTE time after the drug has been withdrawn Infectious Diseases: An Official from sale, but must be made prior to 148 AND DEXTROSE Publication of the Infectious Diseases Society of America, 36(1):70–78, January 5% (dextrose, 5 g/100 mL; magnesium approving an ANDA that refers to the 1, 2003. chloride, 30 mg/100 mL; potassium listed drug (§ 314.161 (21 CFR 314.161)). 30. de Boer, M.G., J.W. de Fijter, F.P. Kroon, chloride, 37 mg/100 mL; sodium FDA may not approve an ANDA that ‘‘Outbreaks and Clustering of acetate, 368 mg/100 mL; sodium does not refer to a listed drug. Pneumocystis Pneumonia in Kidney chloride, 526 mg/100 mL; sodium PLASMA–LYTE M AND DEXTROSE Transplant Recipients: A Systematic gluconate, 502 mg/100 mL) were not 5% (calcium chloride, 37 mg/100 mL; Review,’’ Medical Mycology, 49(7):673– withdrawn from sale for reasons of dextrose, 5 g/100 mL; magnesium 680, October 2011. chloride, 30 mg/100 mL; potassium 31. Sonego, M., M.C. Pellegrin, G. Becker, et safety or effectiveness. This al., ‘‘Risk Factors for Mortality from determination means that FDA will not chloride, 119 mg/100 mL; sodium Acute Lower Respiratory Infections begin procedures to withdraw approval acetate, 161 mg/100 mL; sodium (ALRI) in Children under Five Years of of abbreviated new drug applications chloride, 94 mg/100 mL; sodium lactate, Age in Low and Middle-Income (ANDAs) that refer to these drug 138 mg/100 mL) is the subject of NDA Countries: A Systematic Review and products, and it will allow FDA to 017390, held by Baxter Healthcare Meta-Analysis of Observational Studies,’’ continue to approve ANDAs that refer to Corp., and initially approved on PLOS One, 10(1):e0116380, 2015. February 1, 1979. PLASMA LYTE 148 32. Morris, A., J.D. Lundgren, H. Masur, et these products as long as they meet relevant legal and regulatory AND DEXTROSE 5% (dextrose, 5 g/100 al., ‘‘Current Epidemiology of Pneumocystis Pneumonia,’’ Emerging requirements. mL; magnesium chloride, 30 mg/100 Infectious Diseases, 10(10):1713–1720, mL; potassium chloride, 37 mg/100 mL; FOR FURTHER INFORMATION CONTACT: sodium acetate, 368 mg/100 mL; sodium October 2004. 33. Avino, L.J., S.M. Naylor, A.M. Roecker, Heather A. Dorsey, Center for Drug chloride, 526 mg/100 mL; sodium ‘‘Pneumocystis jirovecii Pneumonia in Evaluation and Research, Food and gluconate, 502 mg/100 mL) is the the Non-HIV-Infected Population,’’ The Drug Administration, 10903 New subject of NDA 017451, held by Baxter Annals of Pharmacotherapy, 50(8):673– Hampshire Ave., Bldg. 51, Rm. 6219, Healthcare Corp., and initially approved 679, August 2016. Silver Spring, MD 20993–0002, 301– on February 2, 1979. PLASMA LYTE M 34. Joint United Nations Programme on HIV/ 796–3601. AIDS (UNAIDS), ‘‘Global Report: AND DEXTROSE 5% is indicated as a SUPPLEMENTARY INFORMATION: In 1984, source of water, electrolytes, and UNAIDS Report on the Global AIDS Epidemic 2013,’’ accessed December 9, Congress enacted the Drug Price calories or as an alkalinizing agent. 2016, available at http://files.unaids.org/ Competition and Patent Term PLASMA LYTE 148 AND DEXTROSE en/media/unaids/contentassets/ Restoration Act of 1984 (Pub. L. 98–417) 5% is indicated as a source of water, documents/epidemiology/2013/gr2013/ (the 1984 amendments), which electrolytes, and calories, or as an UNAIDS_Global_Report_2013_en.pdf. authorized the approval of duplicate alkalinizing agent. 35. WHO, ‘‘Neglected Tropical Diseases,’’ versions of drug products under an PLASMA–LYTE M AND DEXTROSE accessed December 9, 2016, available at ANDA procedure. ANDA applicants 5% (calcium chloride, 37 mg/100 mL; daltland on DSKBBV9HB2PROD with NOTICES http://www.who.int/neglected_diseases/ diseases/en/. must, with certain exceptions, show that dextrose, 5 g/100 mL; magnesium the drug for which they are seeking chloride, 30 mg/100 mL; potassium Dated: August 21, 2018. approval contains the same active chloride, 119 mg/100 mL; sodium Leslie Kux, ingredient in the same strength and acetate, 161 mg/100 mL; sodium Associate Commissioner for Policy. dosage form as the ‘‘listed drug,’’ which chloride, 94 mg/100 mL; sodium lactate, [FR Doc. 2018–18313 Filed 8–23–18; 8:45 am] is a version of the drug that was 138 mg/100 mL) and PLASMA LYTE BILLING CODE 4164–01–P previously approved. ANDA applicants 148 AND DEXTROSE VerDate Sep<11>2014 19:17 Aug 23, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1

42900 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 5% (dextrose, 5 g/100 mL; magnesium chloride, 94 mg/100 mL; sodium lactate, ACTION: Notice. chloride, 30 mg/100 mL; potassium 138 mg/100 mL) and PLASMA LYTE chloride, 37 mg/100 mL; sodium 148 AND DEXTROSE 5% (dextrose, 5 g/ SUMMARY: The Food and Drug acetate, 368 mg/100 mL; sodium 100 mL; magnesium chloride, 30 mg/ Administration (FDA or Agency) is chloride, 526 mg/100 mL; sodium 100 mL; potassium chloride, 37 mg/100 announcing an opportunity for public gluconate, 502 mg/100 mL) are currently mL; sodium acetate, 368 mg/100 mL; comment on the proposed collection of listed in the ‘‘Discontinued Drug sodium chloride, 526 mg/100 mL; certain information by the Agency. Product List’’ section of the Orange sodium gluconate, 502 mg/100 mL) from Under the Paperwork Reduction Act of Book. In the Federal Register of October sale. We have also independently 1995 (PRA), Federal Agencies are 13, 2015 (80 FR 61426), FDA announced evaluated relevant literature and data required to publish notice in the that it was withdrawing approval of for possible postmarketing adverse Federal Register concerning each NDAs 017390 and 017451, effective proposed collection of information, events. We have reviewed the available November 12, 2015. including each proposed extension of an evidence and determined that these Fresenius Kabi USA, LLC, submitted existing collection of information, and drug products were not withdrawn from two citizen petitions dated March 2, to allow 60 days for public comment in sale for reasons of safety or 2018 (Docket No. FDA–2018–P–0964), response to the notice. This notice effectiveness. and March 5, 2018 (Docket No. FDA– solicits comments on the information Accordingly, the Agency will 2018–P–0967), under 21 CFR 10.30, collection requirements relating to the continue to list PLASMA–LYTE M AND requesting that the Agency determine Prescription Drug User Fee Cover Sheet, DEXTROSE 5% (calcium chloride, 37 whether PLASMA–LYTE M AND Form FDA 3397, that must be submitted mg/100 mL; dextrose, 5 g/100 mL; DEXTROSE 5% (calcium chloride, 37 along with certain drug and biological magnesium chloride, 30 mg/100 mL; product applications. mg/100 mL; dextrose, 5 g/100 mL; potassium chloride, 119 mg/100 mL; magnesium chloride, 30 mg/100 mL; DATES: Submit either electronic or sodium acetate, 161 mg/100 mL; sodium potassium chloride, 119 mg/100 mL; chloride, 94 mg/100 mL; sodium lactate, written comments on the collection of sodium acetate, 161 mg/100 mL; sodium information by October 23, 2018. 138 mg/100 mL) and PLASMA LYTE chloride, 94 mg/100 mL; sodium lactate, 148 AND DEXTROSE ADDRESSES: You may submit comments 138 mg/100 mL) and PLASMA LYTE 5% (dextrose, 5 g/100 mL; magnesium as follows. Please note that late, 148 AND DEXTROSE chloride, 30 mg/100 mL; potassium untimely filed comments will not be 5% (dextrose, 5 g/100 mL; magnesium chloride, 37 mg/100 mL; sodium considered. Electronic comments must chloride, 30 mg/100 mL; potassium acetate, 368 mg/100 mL; sodium be submitted on or before October 23, chloride, 37 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium 2018. The https://www.regulations.gov acetate, 368 mg/100 mL; sodium gluconate, 502 mg/100 mL) in the electronic filing system will accept chloride, 526 mg/100 mL; sodium ‘‘Discontinued Drug Product List’’ comments until midnight Eastern Time gluconate, 502 mg/100 mL) were section of the Orange Book. The at the end of October 23, 2018. withdrawn from sale for reasons of ‘‘Discontinued Drug Product List’’ Comments received by mail/hand safety or effectiveness. delineates, among other items, drug delivery/courier (for written/paper After considering the citizen petitions submissions) will be considered timely products that have been discontinued and reviewing Agency records and if they are postmarked or the delivery from marketing for reasons other than based on the information we have at this service acceptance receipt is on or safety or effectiveness. ANDAs that refer time, FDA has determined under before that date. to these drug products may be approved § 314.161 that PLASMA–LYTE M AND by the Agency as long as they meet all Electronic Submissions DEXTROSE 5% (calcium chloride, 37 mg/100 mL; other legal and regulatory requirements Submit electronic comments in the dextrose, 5 g/100 mL; magnesium for the approval of ANDAs. If FDA following way: chloride, 30 mg/100 mL; potassium determines that labeling for these drug • Federal eRulemaking Portal: chloride, 119 mg/100 mL; sodium products should be revised to meet https://www.regulations.gov. Follow the acetate, 161 mg/100 mL; sodium current standards, the Agency will instructions for submitting comments. chloride, 94 mg/100 mL; sodium lactate, advise ANDA applicants to submit such Comments submitted electronically, 138 mg/100 mL) and PLASMA LYTE labeling. including attachments, to https:// 148 AND DEXTROSE 5% (dextrose, 5 g/ Dated: August 20, 2018. www.regulations.gov will be posted to 100 mL; magnesium chloride, 30 mg/ Leslie Kux, the docket unchanged. Because your 100 mL; potassium chloride, 37 mg/100 Associate Commissioner for Policy. comment will be made public, you are mL; sodium acetate, 368 mg/100 mL; [FR Doc. 2018–18311 Filed 8–23–18; 8:45 am] solely responsible for ensuring that your sodium chloride, 526 mg/100 mL; BILLING CODE 4164–01–P comment does not include any sodium gluconate, 502 mg/100 mL) confidential information that you or a were not withdrawn for reasons of third party may not wish to be posted, safety or effectiveness. The petitioner DEPARTMENT OF HEALTH AND such as medical information, your or has identified no data or other HUMAN SERVICES anyone else’s Social Security number, or information suggesting that these drug confidential business information, such products were withdrawn for reasons of Food and Drug Administration as a manufacturing process. Please note safety or effectiveness. that if you include your name, contact We have carefully reviewed our files [Docket No. FDA–2005–N–0101] information, or other information that daltland on DSKBBV9HB2PROD with NOTICES for records concerning the withdrawal Agency Information Collection identifies you in the body of your of PLASMA–LYTE M AND DEXTROSE Activities; Proposed Collection; comments, that information will be 5% (calcium chloride, 37 mg/100 mL; Comment Request; Prescription Drug posted on https://www.regulations.gov. dextrose, 5 g/100 mL; magnesium User Fee Cover Sheet; Form FDA 3397 • If you want to submit a comment chloride, 30 mg/100 mL; potassium with confidential information that you chloride, 119 mg/100 mL; sodium AGENCY: Food and Drug Administration, do not wish to be made available to the acetate, 161 mg/100 mL; sodium HHS. public, submit the comment as a VerDate Sep<11>2014 19:17 Aug 23, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1


Document Created: 2018-08-24 04:14:41
Document Modified: 2018-08-24 04:14:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactHeather A. Dorsey, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301- 796-3601.
FR Citation83 FR 42899 
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