Neomycin Sulfate for Prescription Compounding; Withdrawal of Approval of One Abbreviated New Drug Application, 1746-1747 [2019-01131]

Download as PDF 1746 Federal Register / Vol. 84, No. 24 / Tuesday, February 5, 2019 / Notices Application No. Drug Applicant ANDA 077895 ......... Ursodiol Capsules USP, 300 mg .......................................... ANDA 078810 ......... Oxaliplatin for Injection, 50 mg/vial and 100 mg/vial ............ ANDA 080420 ......... ANDA 080421 ......... ANDA 083083 ......... Lidocaine Hydrochloride (HCl) Injection USP, 1%, 1.5%, and 2%. Procaine HCl Injection USP, 1% and 2% ............................. Lidocaine HCl Injection USP, 1% and 2% ............................ ANDA 083744 ......... Lidocaine HCl Injection USP, 0.5%, 1%, 1.5%, and 2% ...... ANDA 083907 ......... ANDA 084571 ......... Lidocaine HCl With Epinephrine Injection USP .................... Lidocaine HCl Injection, 10 mg/20 mL and 10 mg/50 mL .... ANDA 084572 ......... ANDA 084720 ......... Lidocaine HCl Injection, 20 mg/20 mL and 20 mg/50 mL .... Lidocaine HCl and Epinephrine Injection USP, 2%; 0.01 mg/mL. Lidocaine HCl and Epinephrine Injection USP, 2%; 0.02 mg/mL. Alphacaine (lidocaine) Ointment, 5% .................................... Impax Laboratories, LLC, 30831 Huntwood Ave., Hayward, CA 94544. Fresenius Kabi Oncology Plc., c/o Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. Lyphomed, Inc., 2045 North Cornell Ave., Melrose Park, IL 60160. Do. Wyeth-Ayerst Laboratories, P.O. Box 8299, Philadelphia, PA 19101. Tera Pharmaceuticals, Inc., 6920 Stanton Ave., Buena Park, CA 90621. Do. Knoll Pharmaceuticals, 30 North Jefferson Rd., Whippany, NJ 07981. Do. Naska Pharmacal Co., Inc., Riverview Rd., P.O. Box 898, Lincolnton, NC 28093. Do. ANDA 084732 ......... ANDA 084947 ......... ANDA 085037 ......... ANDA 085677 ......... ANDA 088051 ......... Lidocaine HCl Injection USP, 1% and 2% ............................ Cortisone Acetate Injectable Suspension USP, 25 mg/mL and 50 mg/mL. Thalitone (chlorthalidone) Tablets USP, 25 mg .................... ANDA 089688 ......... Lidocaine HCl Topical Solution USP, 4% ............................. ANDA 091212 ......... Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg. Vancomycin HCl for Injection USP, EQ 500 mg base/vial and EQ 1gram (g) base/vial. Vancomycin HCl for Injection USP, EQ 5 g base/vial and EQ 10 g base/vial (Pharmacy Bulk Package). ANDA 091377 ......... ANDA 206243 ......... Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of March 7, 2019. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on March 7, 2019, may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: January 16, 2019. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2019–01129 Filed 2–4–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:22 Feb 04, 2019 Jkt 247001 Carlisle Laboratories, Inc., 404 Doughty Blvd., Inwood, NY 11696. Akorn, Inc., P.O. Box 1220, Decatur, IL 62525. Steris Laboratories, Inc., 620 North 51st Ave., Phoenix, AZ 85043. Casper Pharma LLC, 2 Tower Center Blvd., Suite 1101C, East Brunswick, NJ 08816. Paco Research, Corp., 1705 Oak St., Lakewood, NJ 08701. Krka, tovarna zdravil, d.d., Novo mesto, c/o KRKA USA, LLC. Xellia Pharmaceuticals ApS, c/o Xellia Pharmaceuticals USA, LLC, 8841 Wadford Dr., Raleigh, NC 27616. Do. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1987–D–0240 (formerly 87D–0315)] Neomycin Sulfate for Prescription Compounding; Withdrawal of Approval of One Abbreviated New Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 061579 for nonsterile neomycin sulfate powder for prescription compounding. The basis for the withdrawal is that the product is no longer considered safe as labeled due to clinical evidence that systemic exposure to neomycin sulfate can induce significant toxicity, including ototoxicity (manifested as sensorineural hearing loss), nephrotoxicity, and neuromuscular blockade. The holder of this ANDA has waived its opportunity for a hearing. DATES: Approval is withdrawn as of February 5, 2019. SUMMARY: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Kate Greenwood, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993–0002, 240–402–1748. SUPPLEMENTARY INFORMATION: In the Federal Register of April 15, 1988, FDA published four documents arising out of the Agency’s finding that systemic absorption of neomycin sulfate can induce significant toxicity, including ototoxicity (manifested as sensorineural hearing loss), nephrotoxicity, and neuromuscular blockade (see generally 53 FR 12644; 53 FR 12658; 53 FR 12662; and 53 FR 12664 (April 15, 1988)). Two of the four documents were issued under docket numbers FDA–1979–N– 0220 and FDA–1987–D–0240 and related to nonsterile neomycin sulfate for prescription compounding.1 Under docket number FDA–1979–N– 0220, FDA published a final rule amending the antibiotic drug FOR FURTHER INFORMATION CONTACT: 1 These documents were originally assigned docket numbers 79N–0155, and 87D–0315. The numbers were changed to FDA–1979–N–0220 and FDA–1987–D–0240, respectively, as a result of FDA’s transition to its new docketing system (Regulations.gov) in January 2008. The other two documents were issued under docket number FDA– 1979–N–0256 (formerly 79N–0151) and related to neomycin sulfate in sterile vials for parenteral use. E:\FR\FM\05FEN1.SGM 05FEN1 Federal Register / Vol. 84, No. 24 / Tuesday, February 5, 2019 / Notices regulations governing the certification of nonsterile neomycin sulfate powder for prescription compounding (53 FR 12644). Based on its evaluation of the written and oral comments received on the proposed rule (44 FR 44180 (July 27, 1979)), and based on other information, FDA concluded that there was a favorable risk:benefit profile for orally administered neomycin sulfate preparations as adjunctive therapy for preoperative suppression of intestinal bacteria and for the treatment of hepatic coma. However, consistent with the findings published in the proposed rule, FDA concluded in the final rule that the risks of adverse reactions from the use of the product for wound irrigation resulted in systemic absorption and a resultant risk of adverse reactions that significantly outweighed any demonstrated benefits. Accordingly, the final rule amended the antibiotic drug regulations by changing the product name from ‘‘neomycin sulfate for prescription compounding’’ to ‘‘neomycin sulfate for compounding oral products’’ and by requiring package insert labeling to provide information concerning the appropriate uses of the product and to warn about the risks associated with inappropriate use. Under docket number FDA–1987–D– 0240, FDA proposed to issue an order under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) withdrawing approval of six antibiotic drug applications and abbreviated antibiotic drug applications (AADAs) 2 for nonsterile neomycin sulfate for prescription compounding products unless the application holders submitted supplemental applications providing for a product name and labeling consistent with the revised name and labeling requirements described in the newly amended antibiotic certification regulations (53 FR 12662).3 In the document, FDA announced the availability of guideline labeling for nonsterile neomycin sulfate for prescription compounding products that manufacturers could adopt to ensure that their labeling would be consistent with the labeling required by the revised antibiotic certification regulations. The proposed order was based on clinical or other experience, 2 The terms ‘‘antibiotic drug applications’’ and ‘‘abbreviated antibiotic drug applications’’ are no longer used. AADAs approved under section 507 of the FD&C Act on or before November 20, 1997, are deemed to have been approved under section 505(j) of the FD&C Act. 3 This proposed regulatory action was necessary because the antibiotic drug certification regulations did not apply to products with applications in which FDA had approved alternative labeling. VerDate Sep<11>2014 17:22 Feb 04, 2019 Jkt 247001 tests, or other scientific data that showed nonsterile neomycin sulfate was unsafe for use except when named ‘‘Neomycin Sulfate for Compounding Oral Products’’ and used in accordance with package insert labeling that provides information concerning appropriate uses and that warns about risks associated with inappropriate use. Under section 505 and the regulations promulgated at 21 CFR parts 310 and 314, the holders of the applications were given the opportunity for a hearing to show why approval should not be withdrawn. One application holder, Pharma-Tek, Inc. (Pharma-Tek), requested a hearing to challenge FDA’s proposal to withdraw approval of its application, AADA 61–579. On December 6, 1988, FDA announced the withdrawal of approval of five of the six applications for nonsterile neomycin sulfate for prescription compounding for which the holders had not requested a hearing (53 FR 49231). The AADA for neomycin sulfate for prescription compounding, AADA 61–579, held by Pharma-Tek, was not withdrawn at that time because of the sponsor’s pending hearing request. Today, this application corresponds to ANDA 061579 held by X-Gen Pharmaceuticals, Inc. (X-Gen). X-Gen informed FDA by letter dated October 9, 2015, that it was withdrawing the hearing request previously filed on behalf of its predecessor Pharma-Tek concerning ANDA 061579. X-Gen also informed FDA that it waived the opportunity for a hearing and, under 21 CFR 314.150(d), X-Gen permitted the Agency to withdraw approval of ANDA 061579 for neomycin sulfate for prescription compounding. For the reasons discussed in the document published in the Federal Register on April 15, 1988, under docket number FDA–1987–D–0240, the Director of FDA’s Center for Drug Evaluation and Research finds that ANDA 061579 was withdrawn from sale for safety and effectiveness reasons (21 CFR 314.161(c)). The Director, under section 505(e) of the FD&C Act and under authority delegated to her by the Commissioner, also finds that new evidence of clinical experience, not contained in ANDA 061579 and not available at the time the application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that nonsterile neomycin sulfate for prescription compounding is not shown to be safe for use under the conditions of use upon the basis of which the application was approved (21 U.S.C. 355(e)). Therefore, approval of ANDA 061579 is hereby withdrawn. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 1747 Under 21 CFR 314.161(e) and 314.162(a)(2), FDA will remove ANDA 061579 from the list of drug products with effective approvals published in FDA’s ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations.’’ Dated: January 23, 2019. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2019–01131 Filed 2–4–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–6702] The Least Burdensome Provisions: Concept and Principles; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘The Least Burdensome Provisions: Concept and Principles.’’ FDA utilizes a least burdensome approach to medical device regulation to eliminate unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. This document describes the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to products meeting the statutory definition of a device regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: The announcement of the guidance is published in the Federal Register on February 5, 2019. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are E:\FR\FM\05FEN1.SGM 05FEN1

Agencies

[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Pages 1746-1747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01131]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1987-D-0240 (formerly 87D-0315)]


Neomycin Sulfate for Prescription Compounding; Withdrawal of 
Approval of One Abbreviated New Drug Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of abbreviated new drug application (ANDA) 061579 
for nonsterile neomycin sulfate powder for prescription compounding. 
The basis for the withdrawal is that the product is no longer 
considered safe as labeled due to clinical evidence that systemic 
exposure to neomycin sulfate can induce significant toxicity, including 
ototoxicity (manifested as sensorineural hearing loss), nephrotoxicity, 
and neuromuscular blockade. The holder of this ANDA has waived its 
opportunity for a hearing.

DATES: Approval is withdrawn as of February 5, 2019.

FOR FURTHER INFORMATION CONTACT: Kate Greenwood, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993-0002, 240-
402-1748.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 15, 1988, 
FDA published four documents arising out of the Agency's finding that 
systemic absorption of neomycin sulfate can induce significant 
toxicity, including ototoxicity (manifested as sensorineural hearing 
loss), nephrotoxicity, and neuromuscular blockade (see generally 53 FR 
12644; 53 FR 12658; 53 FR 12662; and 53 FR 12664 (April 15, 1988)). Two 
of the four documents were issued under docket numbers FDA-1979-N-0220 
and FDA-1987-D-0240 and related to nonsterile neomycin sulfate for 
prescription compounding.\1\
---------------------------------------------------------------------------

    \1\ These documents were originally assigned docket numbers 79N-
0155, and 87D-0315. The numbers were changed to FDA-1979-N-0220 and 
FDA-1987-D-0240, respectively, as a result of FDA's transition to 
its new docketing system (Regulations.gov) in January 2008. The 
other two documents were issued under docket number FDA-1979-N-0256 
(formerly 79N-0151) and related to neomycin sulfate in sterile vials 
for parenteral use.
---------------------------------------------------------------------------

    Under docket number FDA-1979-N-0220, FDA published a final rule 
amending the antibiotic drug

[[Page 1747]]

regulations governing the certification of nonsterile neomycin sulfate 
powder for prescription compounding (53 FR 12644). Based on its 
evaluation of the written and oral comments received on the proposed 
rule (44 FR 44180 (July 27, 1979)), and based on other information, FDA 
concluded that there was a favorable risk:benefit profile for orally 
administered neomycin sulfate preparations as adjunctive therapy for 
preoperative suppression of intestinal bacteria and for the treatment 
of hepatic coma. However, consistent with the findings published in the 
proposed rule, FDA concluded in the final rule that the risks of 
adverse reactions from the use of the product for wound irrigation 
resulted in systemic absorption and a resultant risk of adverse 
reactions that significantly outweighed any demonstrated benefits. 
Accordingly, the final rule amended the antibiotic drug regulations by 
changing the product name from ``neomycin sulfate for prescription 
compounding'' to ``neomycin sulfate for compounding oral products'' and 
by requiring package insert labeling to provide information concerning 
the appropriate uses of the product and to warn about the risks 
associated with inappropriate use.
    Under docket number FDA-1987-D-0240, FDA proposed to issue an order 
under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 355(e)) withdrawing approval of six antibiotic drug 
applications and abbreviated antibiotic drug applications (AADAs) \2\ 
for nonsterile neomycin sulfate for prescription compounding products 
unless the application holders submitted supplemental applications 
providing for a product name and labeling consistent with the revised 
name and labeling requirements described in the newly amended 
antibiotic certification regulations (53 FR 12662).\3\ In the document, 
FDA announced the availability of guideline labeling for nonsterile 
neomycin sulfate for prescription compounding products that 
manufacturers could adopt to ensure that their labeling would be 
consistent with the labeling required by the revised antibiotic 
certification regulations. The proposed order was based on clinical or 
other experience, tests, or other scientific data that showed 
nonsterile neomycin sulfate was unsafe for use except when named 
``Neomycin Sulfate for Compounding Oral Products'' and used in 
accordance with package insert labeling that provides information 
concerning appropriate uses and that warns about risks associated with 
inappropriate use. Under section 505 and the regulations promulgated at 
21 CFR parts 310 and 314, the holders of the applications were given 
the opportunity for a hearing to show why approval should not be 
withdrawn. One application holder, Pharma-Tek, Inc. (Pharma-Tek), 
requested a hearing to challenge FDA's proposal to withdraw approval of 
its application, AADA 61-579. On December 6, 1988, FDA announced the 
withdrawal of approval of five of the six applications for nonsterile 
neomycin sulfate for prescription compounding for which the holders had 
not requested a hearing (53 FR 49231). The AADA for neomycin sulfate 
for prescription compounding, AADA 61-579, held by Pharma-Tek, was not 
withdrawn at that time because of the sponsor's pending hearing 
request. Today, this application corresponds to ANDA 061579 held by X-
Gen Pharmaceuticals, Inc. (X-Gen).
---------------------------------------------------------------------------

    \2\ The terms ``antibiotic drug applications'' and ``abbreviated 
antibiotic drug applications'' are no longer used. AADAs approved 
under section 507 of the FD&C Act on or before November 20, 1997, 
are deemed to have been approved under section 505(j) of the FD&C 
Act.
    \3\ This proposed regulatory action was necessary because the 
antibiotic drug certification regulations did not apply to products 
with applications in which FDA had approved alternative labeling.
---------------------------------------------------------------------------

    X-Gen informed FDA by letter dated October 9, 2015, that it was 
withdrawing the hearing request previously filed on behalf of its 
predecessor Pharma-Tek concerning ANDA 061579. X-Gen also informed FDA 
that it waived the opportunity for a hearing and, under 21 CFR 
314.150(d), X-Gen permitted the Agency to withdraw approval of ANDA 
061579 for neomycin sulfate for prescription compounding.
    For the reasons discussed in the document published in the Federal 
Register on April 15, 1988, under docket number FDA-1987-D-0240, the 
Director of FDA's Center for Drug Evaluation and Research finds that 
ANDA 061579 was withdrawn from sale for safety and effectiveness 
reasons (21 CFR 314.161(c)). The Director, under section 505(e) of the 
FD&C Act and under authority delegated to her by the Commissioner, also 
finds that new evidence of clinical experience, not contained in ANDA 
061579 and not available at the time the application was approved, 
evaluated together with the evidence available to the Secretary when 
the application was approved, shows that nonsterile neomycin sulfate 
for prescription compounding is not shown to be safe for use under the 
conditions of use upon the basis of which the application was approved 
(21 U.S.C. 355(e)). Therefore, approval of ANDA 061579 is hereby 
withdrawn.
    Under 21 CFR 314.161(e) and 314.162(a)(2), FDA will remove ANDA 
061579 from the list of drug products with effective approvals 
published in FDA's ``Approved Drug Products With Therapeutic 
Equivalence Evaluations.''

    Dated: January 23, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-01131 Filed 2-4-19; 8:45 am]
 BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.