Determination That Metaxalone Tablets, 640 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 35648-35649 [2018-16031]

Download as PDF 35648 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices Jeffery M. Zirger, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2018–16090 Filed 7–26–18; 8:45 am] the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. BILLING CODE 4163–18–P Dia Taylor, Acting Chief Operating Officer, Centers for Disease Control and Prevention. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2018–16103 Filed 7–26–18; 8:45 am] BILLING CODE 4163–19–P Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)—Health Disparities Subcommittee (HDS) Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of meeting. AGENCY: In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Advisory Committee to the Director, Centers for Disease Control and Prevention—Health Disparities Subcommittee (ACD, CDC–HDS). This meeting is open to the public, limited only by the 50 audio phone lines. The public is also welcome to listen to the meeting by teleconference. Please dial (866) 918–8397 and enter code 9346283. There are 50 lines available. The public comment period is from 3:15 p.m.–3:20 p.m. DATES: The meeting will be held on October 9, 2018, 1:30 p.m. to 3:30 p.m., EDT. ADDRESSES: Teleconference phone (866) 918–8397 and enter code 9346283. FOR FURTHER INFORMATION CONTACT: Leandris Liburd, Ph.D., M.P.H., M.A., Designated Federal Officer, Health Disparities Subcommittee, Advisory Committee to the Director, CDC, 1600 Clifton Road NE, M/S K–77, Atlanta, Georgia 30329. Telephone (404) 498– 6482, Email: ACDirector@cdc.gov. SUPPLEMENTARY INFORMATION: Purpose: The Subcommittee will provide counsel to the CDC Director through the ACD on strategic and other health disparities and health equity issues and provide guidance on opportunities for CDC. Matters to be Considered: The agenda will include discussions on new member orientation. This meeting will provide information to new members regarding their role & duties on this subcommittee. Agenda items are subject to change as priorities dictate. The Director, Management Analysis and Services Office, has been delegated amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–P–1283] Determination That Metaxalone Tablets, 640 Milligrams, Were 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 metaxalone tablets, 640 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for metaxalone tablets, 640 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Glen Cheng, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6217, Silver Spring, MD 20993–0002, 301–796–1494. 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. SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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 (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. Metaxalone tablets, 640 mg, are the subject of NDA 22–503, held by Primus Pharmaceuticals, Inc., and initially approved on June 1, 2015. Metaxalone tablets, 640 mg, are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. In a letter dated September 30, 2015, the previous NDA holder CorePharma, LLC notified FDA that metaxalone tablets, 640 mg, were discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Sovereign Pharmaceuticals, LLC submitted a citizen petition dated March 26, 2018 (Docket No. FDA–2018– P–1283), under 21 CFR 10.30, requesting that the Agency determine whether metaxalone tablets, 640 mg, were 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 metaxalone tablets, 640 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that metaxalone tablets, 640 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of metaxalone tablets, 640 mg, 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 this drug product was E:\FR\FM\27JYN1.SGM 27JYN1 35649 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list metaxalone tablets, 640 mg, 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 metaxalone tablets, 640 mg, 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 this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: July 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–16031 Filed 7–26–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0007] Generic Drug User Fee Rates for Fiscal Year 2019 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to SUMMARY: assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2019 rates for GDUFA II fees. FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE–14202J, Silver Spring, MD 20993–0002, 240–402–4585. SUPPLEMENTARY INFORMATION: I. Background Sections 744A and 744B of the FD&C Act (21 U.S.C. 379j–41 and 379j–42) establish fees associated with human generic drug products. Fees are assessed on: (1) Certain types of applications for human generic drug products; (2) certain facilities where APIs and FDFs are produced; (3) certain DMFs associated with human generic drug products; and (4) generic drug applicants who have approved ANDAs (the program fee) (see section 744B(a)(2)–(5) of the FD&C Act). GDUFA II stipulates that user fees should total $493,600,000 annually adjusted each year for inflation. For FY 2019, the generic drug fee rates are: ANDA ($178,799), DMF ($55,013), domestic API facility ($44,226), foreign API facility ($59,226), domestic FDF facility ($211,305), foreign FDF facility ($226,305), domestic CMO facility ($70,435), foreign CMO facility ($85,435), large size operation generic drug applicant program ($1,862,167), medium size operation generic drug applicant program ($744,867), and small business generic drug applicant program ($186,217). These fees are effective on October 1, 2018, and will remain in effect through September 30, 2019. II. Fee Revenue Amount for FY 2019 The base revenue amount for FY 2019 is $493,600,000, as set in the statute (see section 744B(b)(1) of the FD&C Act). GDUFA II directs FDA to use the yearly revenue amount as a starting point to set the fee rates for each fee type. For more information about GDUFA II, please refer to the FDA website (https:// www.fda.gov/gdufa). The ANDA, DMF, API facility, FDF facility, CMO facility, and generic drug applicant program fee (GDUFA program fee) calculations for FY 2019 are described in this document. GDUFA II specifies that the $493,600,000 is to be adjusted for inflation increases for FY 2019 using two separate adjustments—one for personnel compensation and benefits (PC&B) and one for non-PC&B costs (see sections 744B(c)(1)(B) and (C) of the FD&C Act). The component of the inflation adjustment for PC&B costs shall be one plus the average annual percent change in the cost of all PC&B paid per full-time equivalent position (FTE) at FDA for the first 3 of the 4 preceding fiscal years, multiplied by the proportion of PC&B costs to total FDA costs of human generic drug activities for the first 3 of the preceding 4 fiscal years (see section 744B(c)(1)(B) of the FD&C Act). Table 1 summarizes the actual cost and total FTE for the specified fiscal years, and provides the percent change from the previous fiscal year and the average percent change over the first 3 of the 4 fiscal years preceding FY 2019. The 3-year average is 2.4152 percent. TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE Fiscal year 2015 Total PC&B .............................................................................. Total FTE ................................................................................. PC&B per FTE ......................................................................... Percent Change from Previous Year ...................................... amozie on DSK3GDR082PROD with NOTICES1 The statute specifies that this 2.4152 percent should be multiplied by the proportion of PC&B expended for $2,232,304,000 15,484 $144,168 2.1136 2016 2017 $2,414,728,159 16,381 $147,408 2.2474 human generic drug activities for the first 3 of the preceding 4 fiscal years. Table 2 shows the amount of PC&B and $2,581,551,000 17,022 $151,660 2.8845 3-Year average .............................. .............................. .............................. 2.4152 the total amount obligated for human generic drug activities from FY 2015 through FY 2017. TABLE 2—PC&B AS A PERCENT OF FEE REVENUES SPENT ON THE PROCESS OF HUMAN GENERIC DRUG APPLICATIONS OVER THE LAST 3 YEARS Fiscal year 2015 PC&B ....................................................................................... Non-PC&B ............................................................................... Total Costs ............................................................................... VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00046 $201,116,305 $251,589,013 $452,705,318 Fmt 4703 Sfmt 4703 2016 $242,963,571 $250,987,599 $493,951,170 E:\FR\FM\27JYN1.SGM 2017 $271,748,229 $262,058,852 $533,807,081 27JYN1 3-Year average .............................. .............................. ..............................

Agencies

[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35648-35649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16031]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-P-1283]


Determination That Metaxalone Tablets, 640 Milligrams, Were 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 metaxalone tablets, 640 milligrams (mg), were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for metaxalone tablets, 640 mg, if all other legal 
and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Glen Cheng, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave. 
Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 301-796-1494.

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.
    Metaxalone tablets, 640 mg, are the subject of NDA 22-503, held by 
Primus Pharmaceuticals, Inc., and initially approved on June 1, 2015. 
Metaxalone tablets, 640 mg, are indicated as an adjunct to rest, 
physical therapy, and other measures for the relief of discomfort 
associated with acute, painful musculoskeletal conditions.
    In a letter dated September 30, 2015, the previous NDA holder 
CorePharma, LLC notified FDA that metaxalone tablets, 640 mg, were 
discontinued, and FDA moved the drug product to the ``Discontinued Drug 
Product List'' section of the Orange Book.
    Sovereign Pharmaceuticals, LLC submitted a citizen petition dated 
March 26, 2018 (Docket No. FDA-2018-P-1283), under 21 CFR 10.30, 
requesting that the Agency determine whether metaxalone tablets, 640 
mg, were 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 metaxalone tablets, 640 mg, were not withdrawn 
for reasons of safety or effectiveness. The petitioner has identified 
no data or other information suggesting that metaxalone tablets, 640 
mg, were withdrawn for reasons of safety or effectiveness. We have 
carefully reviewed our files for records concerning the withdrawal of 
metaxalone tablets, 640 mg, 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 this drug product was

[[Page 35649]]

not withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list metaxalone tablets, 
640 mg, 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 
metaxalone tablets, 640 mg, 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 this drug product should 
be revised to meet current standards, the Agency will advise ANDA 
applicants to submit such labeling.

    Dated: July 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16031 Filed 7-26-18; 8:45 am]
 BILLING CODE 4164-01-P

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