Determination That AXIRON (Testosterone) Transdermal Metered Solution, 30 Milligrams/1.5 Milliliter Actuation, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 56087-56088 [2018-24604]

Download as PDF Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices Application No. Drug Applicant ANDA 040747 ...................... Benzphetamine Hydrochloride (HCl) Tablets, 25 milligrams (mg) and 50 mg. Gentamicin Sulfate Injection USP, Equivalent to (EQ) 10 mg base/milliliter (mL) and EQ 40 mg base/mL. Isoflurane USP, 99.9% .................................................... Tedor Pharma, Inc., 400 Highland Corporate Dr., Cumberland, RI 02864. Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045. Fresenius Kabi USA, LLC. ANDA 062356 ...................... ANDA 074097 ...................... ANDA 076484 ...................... ANDA 080504 ...................... ANDA 083559 ...................... ANDA 084315 ...................... ANDA 084850 ...................... ANDA 086389 ...................... ANDA 087863 ...................... Ciprofloxacin Injection USP, 200 mg/20 mL and 400 mg/40 mL. Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL; 2% and 0.02 mg/mL; 2%. Lidocaine HCl Injection, 2%. Mepivacaine HCl Injection, 3% ....................................... Dexamethasone Acetate Injectable Suspension USP, EQ 8 mg base/mL. Levonordefrin and Mepivacaine HCl Injection, 2%; 0.05 mg/mL. Lidocaine HCl Viscous Oral Topical Solution USP, 2% Choledyl SA (oxtriphylline) Extended-Release Tablets USP, 400 mg. Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of December 10, 2018. 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 December 10, 2018 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: November 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–24605 Filed 11–8–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–P–2506] khammond on DSK30JT082PROD with NOTICES 56087 Determination That AXIRON (Testosterone) Transdermal Metered Solution, 30 Milligrams/1.5 Milliliter Actuation, Was 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 AXIRON (testosterone) SUMMARY: VerDate Sep<11>2014 17:36 Nov 08, 2018 Jkt 247001 Belmora LLC, 2231 Crystal Dr., #1000, Arlington, VA 22202. Do. Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. Belmora LLC. International Medication Systems, Ltd., 1886 Santa Anita Ave., South El Monte, CA 91733. Warner Chilcott Co., LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. transdermal metered solution, 30 milligrams (mg)/1.5 milliliter (mL) actuation, was 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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product if 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. 6236, Silver Spring, MD 20993–0002, 301–796–8363. 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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 (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. AXIRON (testosterone) transdermal metered solution, 30 mg/1.5 mL actuation, is the subject of NDA 022504, held by Eli Lilly and Company and initially approved on November 23, 2010. AXIRON is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. In a letter dated September 5, 2017, Eli Lilly and Company requested withdrawal of NDA 022504 for AXIRON (testosterone). Eli Lilly and Company later submitted a letter dated September 7, 2017 correcting a typographical error in the September 5, 2017 letter. In the Federal Register of June 21, 2018 (83 FR 28856), FDA announced that it was withdrawing approval of NDA 022504, effective July 23, 2018. K&L Gates LLP submitted a citizen petition received by FDA on June 27, E:\FR\FM\09NON1.SGM 09NON1 56088 Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices khammond on DSK30JT082PROD with NOTICES 2018 (Docket No. FDA–2018–P–2506), under 21 CFR 10.25 and 21 CFR 10.30, requesting that the Agency determine whether AXIRON (testosterone) transdermal metered solution, 30 mg/1.5 mL actuation, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that AXIRON (testosterone) transdermal metered solution, 30 mg/1.5 mL actuation, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that AXIRON (testosterone) transdermal metered solution, 30 mg/1.5 mL actuation, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of AXIRON (testosterone) transdermal metered solution, 30 mg/1.5 mL actuation, 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 this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list AXIRON (testosterone) transdermal metered solution, 30 mg/1.5 mL actuation, 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. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs that refer to this drug product may also 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 this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: November 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–24604 Filed 11–8–18; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:36 Nov 08, 2018 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Intent To Prepare an Environmental Impact Statement and Notice of Scoping Meeting AGENCY: National Institutes of Health, HHS. ACTION: Notice. In accordance with the National Environmental Policy Act, the National Institutes of Health (NIH) is issuing this notice to advise the public that an environmental impact statement will be prepared for the Surgery, Radiology and Lab Medicine Building with associated Utility Vault and Patient Parking Garage project located on the National Institutes of Health, Bethesda Campus, Bethesda, Maryland. DATES: The Scoping Meeting is planned for November 28, 2018, from 6 p.m.-9 p.m., with the formal presentation to begin at 7 p.m. Scoping comments must be postmarked no later than December 29, 2018, to ensure they are considered. ADDRESSES: The Scoping Meeting will be held at 6001 Executive Boulevard, Rockville, MD 20852. All comments and questions on the Scoping Meeting and the Environmental Impact Statement should be directed to Valerie Nottingham, Deputy Director, Division of Environmental Protection, Office of Research Facilities, NIH, B13/2S11, 9000 Rockville Pike, Bethesda, Maryland 20892, telephone 301–496– 7775; fax 301–480–0204; or email: nihnepa@mail.nih.gov. FOR FURTHER INFORMATION CONTACT: Valerie Nottingham, Deputy Director, Division of Environmental Protection, Office of Research Facilities, NIH, B13/ 2S11, 9000 Rockville Pike, Bethesda, Maryland 20892, telephone 301–496– 7775; fax 301–480–0204; or email: nihnepa@mail.nih.gov. For the purpose of National Institutes of Health (NIH) and its National Environmental Policy Act (NEPA) procedures, the delegation of authority to administer, interpret and oversee the applicable environmental laws, Executive Orders and regulations for the NIH including the authority to oversee and manage the NIH NEPA program for assessing environmental impacts and publish final decisions has been given to the Director, Office of Research Facilities Development and Operation, Mr. Daniel G. Wheeland. SUPPLEMENTARY INFORMATION: The NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 enhance health, lengthen life, and reduce illness and disability. In order to fulfill and uphold this mission the infrastructure of the NIH Bethesda Campus must be able to support the NIH’s biomedical research programs. The proposed Surgery, Radiology and Lab Medicine Building with associated Utility Vault and Patient Parking Garage project is to house General Radiology and Imaging Services (RADIS), the Department of Perioperative Medicine (DPM), the Department of Laboratory Medicine (DLM) and the relocated functions for the National Cancer Institute (NCI) in a state-of-the-art, safe, functionally efficient, flexible and costeffective facility. During the study period, NIH expanded the building program to also include space for the National Heart, Lung & Blood Institute’s (NHLBI) Cardiovascular Intervention Program (Cath Lab) and for the Interventional Radiology (IR) Program. The proposed project consists of nine (9) levels above grade (including interstitial floors and a roof penthouse) and two (2) levels below grade. The proposed 505,200 building gross square feet (BGSF) of new construction will be linked to the west lab wing of the existing CRC (Building 10), which will include an additional 82,960 BGSF of interior renovation. The proposed new building addition foot print of 53,270 BGSF will be positioned between the CRC and Convent Drive. The proposed project scope also includes the relocation of a portion of the existing campus utility tunnel, reconstruction of the displaced children’s playground and connection to the new Pedestrian Tunnel that will be constructed with the proposed Patient Parking Garage across Convent Drive. Additionally, the project will include the installation of supporting infrastructure, such as emergency generators and medical gas storage, in the new Utility Vault and Utility Yard that will be constructed across Convent Drive as part of a separate, enabling project. In accordance with 40 CFR 1500–1508 and Health and Human Services (HHS) environmental procedures, NIH will prepare an Environmental Impact Statement (EIS) for the proposed project. The EIS will evaluate the impacts of the alternatives should development occur as proposed. Among the items the EIS will examine are the implications of the project on community infrastructure, including, but not limited to, utilities, storm water management, traffic and transportation, and other public services. To ensure that the public is afforded the greatest opportunity to participate in E:\FR\FM\09NON1.SGM 09NON1

Agencies

[Federal Register Volume 83, Number 218 (Friday, November 9, 2018)]
[Notices]
[Pages 56087-56088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24604]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-P-2506]


Determination That AXIRON (Testosterone) Transdermal Metered 
Solution, 30 Milligrams/1.5 Milliliter Actuation, Was 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 AXIRON (testosterone) transdermal metered solution, 30 
milligrams (mg)/1.5 milliliter (mL) actuation, was 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 this drug product, and it 
will allow FDA to continue to approve ANDAs that refer to the product 
if 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. 6236, Silver Spring, MD 20993-0002, 301-796-8363.

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.
    AXIRON (testosterone) transdermal metered solution, 30 mg/1.5 mL 
actuation, is the subject of NDA 022504, held by Eli Lilly and Company 
and initially approved on November 23, 2010. AXIRON is indicated for 
replacement therapy in males for conditions associated with a 
deficiency or absence of endogenous testosterone.
    In a letter dated September 5, 2017, Eli Lilly and Company 
requested withdrawal of NDA 022504 for AXIRON (testosterone). Eli Lilly 
and Company later submitted a letter dated September 7, 2017 correcting 
a typographical error in the September 5, 2017 letter. In the Federal 
Register of June 21, 2018 (83 FR 28856), FDA announced that it was 
withdrawing approval of NDA 022504, effective July 23, 2018.
    K&L Gates LLP submitted a citizen petition received by FDA on June 
27,

[[Page 56088]]

2018 (Docket No. FDA-2018-P-2506), under 21 CFR 10.25 and 21 CFR 10.30, 
requesting that the Agency determine whether AXIRON (testosterone) 
transdermal metered solution, 30 mg/1.5 mL actuation, was withdrawn 
from sale for reasons of safety or effectiveness.
    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 AXIRON (testosterone) transdermal metered 
solution, 30 mg/1.5 mL actuation, was not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that AXIRON (testosterone) transdermal metered 
solution, 30 mg/1.5 mL actuation, was withdrawn for reasons of safety 
or effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of AXIRON (testosterone) transdermal metered 
solution, 30 mg/1.5 mL actuation, 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 
this drug product was withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list AXIRON (testosterone) 
transdermal metered solution, 30 mg/1.5 mL actuation, 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. FDA will not begin procedures to withdraw 
approval of approved ANDAs that refer to this drug product. Additional 
ANDAs that refer to this drug product may also 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 this 
drug product should be revised to meet current standards, the Agency 
will advise ANDA applicants to submit such labeling.

    Dated: November 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24604 Filed 11-8-18; 8:45 am]
 BILLING CODE 4164-01-P