83 FR 56086 - Tedor Pharma, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 218 (November 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 218 (November 9, 2018)
| Page Range | 56086-56087 | |
| FR Document | 2018-24605 |
[Federal Register Volume 83, Number 218 (Friday, November 9, 2018)] [Notices] [Pages 56086-56087] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24605] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-4099] Tedor Pharma, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of December 10, 2018. FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, [email protected]. SUPPLEMENTARY INFORMATION: The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under Sec. 314.150(c) is without prejudice to refiling. [[Page 56087]] ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ ANDA 040747................. Benzphetamine Tedor Pharma, Inc., Hydrochloride (HCl) 400 Highland Tablets, 25 Corporate Dr., milligrams (mg) and Cumberland, RI 50 mg. 02864. ANDA 062356................. Gentamicin Sulfate Fresenius Kabi USA, Injection USP, LLC, Three Equivalent to (EQ) Corporate Dr., Lake 10 mg base/ Zurich, IL 60047. milliliter (mL) and EQ 40 mg base/mL. ANDA 074097................. Isoflurane USP, Hospira, Inc., 275 99.9%. North Field Dr., Bldg. H1, Lake Forest, IL 60045. ANDA 076484................. Ciprofloxacin Fresenius Kabi USA, Injection USP, 200 LLC. mg/20 mL and 400 mg/ 40 mL. ANDA 080504................. Epinephrine and Belmora LLC, 2231 Lidocaine HCl Crystal Dr., #1000, Injection, 0.01 mg/ Arlington, VA mL; 2% and 0.02 mg/ 22202. mL; 2%. Lidocaine HCl Injection, 2%.. ANDA 083559................. Mepivacaine HCl Do. Injection, 3%. ANDA 084315................. Dexamethasone Watson Laboratories, Acetate Injectable Inc., Subsidiary of Suspension USP, EQ Teva 8 mg base/mL. Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 084850................. Levonordefrin and Belmora LLC. Mepivacaine HCl Injection, 2%; 0.05 mg/mL. ANDA 086389................. Lidocaine HCl International Viscous Oral Medication Systems, Topical Solution Ltd., 1886 Santa USP, 2%. Anita Ave., South El Monte, CA 91733. ANDA 087863................. Choledyl SA Warner Chilcott Co., (oxtriphylline) LLC, Subsidiary of Extended-Release Teva Tablets USP, 400 mg. Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ------------------------------------------------------------------------ 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
![56086 Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices
CMS–R–240 Prospective Payments for (OMB control number: 0938–0798); Frequency: Hourly; Affected Public:
Hospital Outpatient Services Frequency: Yearly; Affected Public: Private Sector (Business or other for-
CMS–10164 Medicare EDI Enrollment Private Sector (Business or other for- profits, Not-for-Profit Institutions);
Form and EDI Registration profits, Not-for-Profit Institutions); Number of Respondents: 193,268;
Under the PRA (44 U.S.C. 3501– Number of Respondents: 750; Total Number of Responses: 193,268; Total
3520), federal agencies must obtain Annual Responses: 13,649,150; Total Annual Hours: 64,423. (For policy
approval from the Office of Management Annual Hours: 680,920 (For policy questions regarding this collection,
and Budget (OMB) for each collection of questions regarding this collection contact Matt Klischer at 410–786–7488.)
information they conduct or sponsor. contact Emily Lipkin at 410–786–3633.) Dated: November 6, 2018.
The term ‘‘collection of information’’ is 2. Type of Information Collection William N. Parham, III,
defined in 44 U.S.C. 3502(3) and 5 CFR Request: Reinstatement of a previously
Director, Paperwork Reduction Staff, Office
1320.3(c) and includes agency requests approved collection; Title of of Strategic Operations and Regulatory
or requirements that members of the Information Collection: Medicare EDI Affairs.
public submit reports, keep records, or Enrollment Form and EDI Registration; [FR Doc. 2018–24592 Filed 11–8–18; 8:45 am]
provide information to a third party. Use: The Congress, recognizing the need
BILLING CODE 4120–01–P
Section 3506(c)(2)(A) of the PRA to simplify the administration of health
requires federal agencies to publish a care transactions, enacted the Health
60-day notice in the Federal Register Insurance Portability and DEPARTMENT OF HEALTH AND
concerning each proposed collection of Accountability Act of 1996 (HIPAA), HUMAN SERVICES
information, including each proposed Public Law 104–191, on August 21,
extension or reinstatement of an existing 1996. Title II, Subtitle F of this Food and Drug Administration
collection of information, before legislation directs the Secretary of the
submitting the collection to OMB for Department of Health and Human [Docket No. FDA–2018–N–4099]
approval. To comply with this Services to develop unique standards
for specified electronic transactions and Tedor Pharma, Inc., et al.; Withdrawal
requirement, CMS is publishing this
code sets for those transactions. The of Approval of 10 Abbreviated New
notice.
purpose of this Subtitle is to improve Drug Applications
Information Collection the Medicare and Medicaid programs in AGENCY: Food and Drug Administration,
1. Type of Information Collection particular and the efficiency and HHS.
Request: Reinstatement of a previously effectiveness of the health care industry
ACTION: Notice.
approved collection; Title of in general through the establishment of
Information Collection: Prospective standards and requirements to facilitate SUMMARY: The Food and Drug
Payments for Hospital Outpatient the electronic transmission of certain Administration (FDA or Agency) is
Services; Use: Section 1833(t) of the Act, health information. This Subtitle also withdrawing approval of 10 abbreviated
as added by section 4523 of the requires that the Secretary adopt new drug applications (ANDAs) from
Balanced Budget Act of 1997 (the BBA) standards for financial and multiple applicants. The applicants
requires the Secretary to establish a administrative transactions, and data notified the Agency in writing that the
prospective payment system (PPS) for elements for those transactions to enable drug products were no longer marketed
hospital outpatient services. Successful health information to be exchanged and requested that the approval of the
implementation of an outpatient PPS electronically. The Standards for applications be withdrawn.
requires that CMS distinguish facilities Electronic Transactions final rule, 45
DATES: Approval is withdrawn as of
or organizations that function as CFR part 162 Subpart K § 162.1101
through Subpart R § 162.1802, December 10, 2018.
departments of hospitals from those that
are freestanding, so that CMS can (hereinafter referred to as ‘‘Transactions FOR FURTHER INFORMATION CONTACT:
determine which services should be Rule’’) published August 17, 2000 Trang Tran, Center for Drug Evaluation
paid under the OPPS, the clinical adopted standards for health care and Research, Food and Drug
laboratory fee schedule, or other transactions and code sets. Subsequent Administration, 10903 New Hampshire
payment provisions applicable to to the Transactions Rule, CMS–0003–P Ave., Bldg. 75, Rm. 1671, Silver Spring,
services furnished to hospital and CMS–0005–P proposed MD 20993–0002, 240–402–7945,
outpatients. Information from the modifications to the adopted standards Trang.Tran@fda.hhs.gov.
reports required under sections essential to permit initial SUPPLEMENTARY INFORMATION: The
413.65(b)(3) and (c) is needed to make implementation of the standards applicants listed in the table have
these determinations. In addition, throughout the entire healthcare informed FDA that these drug products
section 1866(b)(2) of the Act authorizes industry. are no longer marketed and have
hospitals and other providers to impose Currently, Medicare contractors have requested that FDA withdraw approval
deductible and coinsurance charges for a process in place to enroll providers for of the applications under the process
facility services, but does not allow such electronic billing and other EDI described in § 314.150(c) (21 CFR
charges by facilities or organizations transactions. In support of the HIPAA 314.150(c)). The applicants have also,
which are not provider-based. Transactions Rule, the purpose of this by their requests, waived their
khammond on DSK30JT082PROD with NOTICES
Implementation of this provision Paperwork Reduction Act (PRA) request opportunity for a hearing. Withdrawal
requires that CMS have information is to establish a common form that is of approval of an application or
from the required reports, so it can sufficient to address all HIPAA abbreviated application under
determine which facilities are provider- transactions. Form Number: CMS–10164 § 314.150(c) is without prejudice to
based. Form Number: CMS–R–240 (OMB control number: 0938–0983); refiling.
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![Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices 56087
Application No. Drug Applicant
ANDA 040747 ...................... Benzphetamine Hydrochloride (HCl) Tablets, 25 milli- Tedor Pharma, Inc., 400 Highland Corporate Dr., Cum-
grams (mg) and 50 mg. berland, RI 02864.
ANDA 062356 ...................... Gentamicin Sulfate Injection USP, Equivalent to (EQ) Fresenius Kabi USA, LLC, Three Corporate Dr., Lake
10 mg base/milliliter (mL) and EQ 40 mg base/mL. Zurich, IL 60047.
ANDA 074097 ...................... Isoflurane USP, 99.9% .................................................... Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake For-
est, IL 60045.
ANDA 076484 ...................... Ciprofloxacin Injection USP, 200 mg/20 mL and 400 Fresenius Kabi USA, LLC.
mg/40 mL.
ANDA 080504 ...................... Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL; Belmora LLC, 2231 Crystal Dr., #1000, Arlington, VA
2% and 0.02 mg/mL; 2%. 22202.
Lidocaine HCl Injection, 2%.
ANDA 083559 ...................... Mepivacaine HCl Injection, 3% ....................................... Do.
ANDA 084315 ...................... Dexamethasone Acetate Injectable Suspension USP, Watson Laboratories, Inc., Subsidiary of Teva Pharma-
EQ 8 mg base/mL. ceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.
ANDA 084850 ...................... Levonordefrin and Mepivacaine HCl Injection, 2%; 0.05 Belmora LLC.
mg/mL.
ANDA 086389 ...................... Lidocaine HCl Viscous Oral Topical Solution USP, 2% International Medication Systems, Ltd., 1886 Santa
Anita Ave., South El Monte, CA 91733.
ANDA 087863 ...................... Choledyl SA (oxtriphylline) Extended-Release Tablets Warner Chilcott Co., LLC, Subsidiary of Teva Pharma-
USP, 400 mg. ceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.
Therefore, approval of the transdermal metered solution, 30 Therapeutic Equivalence Evaluations,’’
applications listed in the table, and all milligrams (mg)/1.5 milliliter (mL) which is known generally as the
amendments and supplements thereto, actuation, was not withdrawn from sale ‘‘Orange Book.’’ Under FDA regulations,
is hereby withdrawn as of December 10, for reasons of safety or effectiveness. drugs are removed from the list if the
2018. Introduction or delivery for This determination means that FDA will Agency withdraws or suspends
introduction into interstate commerce of not begin procedures to withdraw approval of the drug’s NDA or ANDA
products without approved new drug approval of abbreviated new drug for reasons of safety or effectiveness or
applications violates section 301(a) and applications (ANDAs) that refer to this if FDA determines that the listed drug
(d) of the Federal Food, Drug, and drug product, and it will allow FDA to was withdrawn from sale for reasons of
Cosmetic Act (21 U.S.C. 331(a) and (d)). continue to approve ANDAs that refer to safety or effectiveness (21 CFR 314.162).
Drug products that are listed in the table the product if they meet relevant legal A person may petition the Agency to
that are in inventory on December 10, and regulatory requirements. determine, or the Agency may
2018 may continue to be dispensed FOR FURTHER INFORMATION CONTACT: determine on its own initiative, whether
until the inventories have been depleted Stacy Kane, Center for Drug Evaluation a listed drug was withdrawn from sale
or the drug products have reached their and Research, Food and Drug for reasons of safety or effectiveness.
expiration dates or otherwise become Administration, 10903 New Hampshire This determination may be made at any
violative, whichever occurs first. Ave., Bldg. 51, Rm. 6236, Silver Spring, time after the drug has been withdrawn
Dated: November 6, 2018. MD 20993–0002, 301–796–8363. from sale, but must be made prior to
Leslie Kux, SUPPLEMENTARY INFORMATION: In 1984, approving an ANDA that refers to the
Congress enacted the Drug Price listed drug (§ 314.161 (21 CFR 314.161)).
Associate Commissioner for Policy.
Competition and Patent Term FDA may not approve an ANDA that
[FR Doc. 2018–24605 Filed 11–8–18; 8:45 am]
Restoration Act of 1984 (Pub. L. 98–417) does not refer to a listed drug.
BILLING CODE 4164–01–P
(the 1984 amendments), which AXIRON (testosterone) transdermal
authorized the approval of duplicate metered solution, 30 mg/1.5 mL
versions of drug products under an actuation, is the subject of NDA 022504,
DEPARTMENT OF HEALTH AND
ANDA procedure. ANDA applicants held by Eli Lilly and Company and
HUMAN SERVICES
must, with certain exceptions, show that initially approved on November 23,
Food and Drug Administration the drug for which they are seeking 2010. AXIRON is indicated for
approval contains the same active replacement therapy in males for
[Docket No. FDA–2018–P–2506] ingredient in the same strength and conditions associated with a deficiency
dosage form as the ‘‘listed drug,’’ which or absence of endogenous testosterone.
Determination That AXIRON
is a version of the drug that was In a letter dated September 5, 2017,
(Testosterone) Transdermal Metered
previously approved. ANDA applicants Eli Lilly and Company requested
Solution, 30 Milligrams/1.5 Milliliter
do not have to repeat the extensive withdrawal of NDA 022504 for AXIRON
Actuation, Was Not Withdrawn From
clinical testing otherwise necessary to (testosterone). Eli Lilly and Company
Sale for Reasons of Safety or
gain approval of a new drug application later submitted a letter dated September
Effectiveness
7, 2017 correcting a typographical error
khammond on DSK30JT082PROD with NOTICES
(NDA).
AGENCY: Food and Drug Administration, The 1984 amendments include what in the September 5, 2017 letter. In the
HHS. is now section 505(j)(7) of the Federal Federal Register of June 21, 2018 (83 FR
ACTION: Notice. Food, Drug, and Cosmetic Act (21 U.S.C. 28856), FDA announced that it was
355(j)(7)), which requires FDA to withdrawing approval of NDA 022504,
SUMMARY: The Food and Drug publish a list of all approved drugs. effective July 23, 2018.
Administration (FDA or Agency) has FDA publishes this list as part of the K&L Gates LLP submitted a citizen
determined that AXIRON (testosterone) ‘‘Approved Drug Products With petition received by FDA on June 27,
VerDate Sep<11>2014 17:36 Nov 08, 2018 Jkt 247001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\09NON1.SGM 09NON1](https://thefederalregister.org/doc/83_FR_56304/page/2.svg)
Document Created: 2018-11-09 03:33:55
Document Modified: 2018-11-09 03:33:55
| 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. | |
| Dates | Approval is withdrawn as of December 10, 2018. | |
| Contact | Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, [email protected] | |
| FR Citation | 83 FR 56086 |
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