Determination That ROBAXIN and ROBAXIN-750 (Methocarbamol), Oral Tablets, 500 Milligrams and 750 Milligrams, and Other Drug Products, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 58674-58675 [2021-23084]

Download as PDF 58674 Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices Dated: October 8, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23081 Filed 10–21–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–1038] Determination That ROBAXIN and ROBAXIN–750 (Methocarbamol), Oral Tablets, 500 Milligrams and 750 Milligrams, and Other Drug Products, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: refer to the products as long as 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, Stacy.Kane@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) Has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act 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 generally known as the ‘‘Orange Book.’’ Under FDA regulations, a drug is 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). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table are no longer being marketed. Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant NDA 011011 ... Methocarbamol ........... Auxilium Pharmaceuticals LLC. Novartis. Promius Pharma, LLC. NDA 019546 ... NDA 019555 ... DYNACIRC .................. DIPROLENE AF .......... NDA 019625 ... NDA 020089 ... NDA 020136 ... ELOCON ..................... ZOVIRAX .................... DEMADEX .................. Isradipine ..................... Betamethasone Dipropionate. Mometasone Furoate .. Acyclovir ...................... Torsemide ................... 500 milligrams (mg); 750 mg. 1 mg/milliliter (mL) ....... Equivalent to (EQ) 200 mg base; EQ 400 mg base. 2.5 mg; 5 mg ............... EQ 0.05% base ........... Tablet; Oral ................. NDA 018704 ... NDA 018917 ... ROBAXIN; ROBAXIN– 750. LOPRESSOR .............. SECTRAL .................... NDA 020198 ... ADALAT CC ................ Nifedipine .................... NDA 020539 ... LAMISIL ...................... NDA 020634 ... LEVAQUIN .................. Terbinafine Hydrochloride. Levofloxacin ................ NDA 020716 ... VICOPROFEN ............. NDA 020738 ... TEVETEN .................... Hydrocodone Bitartrate; Ibuprofen. Eprosartan Mesylate ... NDA 021001 ... AXERT ........................ Almotriptan Malate ...... NDA 022205 ... GIAZO ......................... Balsalazide Disodium .. NDA 022439 ... ZUTRIPRO .................. Chlorpheniramine Maleate, Hydrocodone Bitartrate, and Pseudoephedrine Hydrochloride. VerDate Sep<11>2014 17:47 Oct 21, 2021 Jkt 256001 Metoprolol Tartrate ...... Acebutolol Hydrochloride. PO 00000 Frm 00039 Injectable; Injection ..... Capsule; Oral .............. Capsule; Oral .............. Cream, Augmented; Topical. Cream; Topical ............ Tablet; Oral ................. Tablet; Oral ................. SmithKline Beecham. Merck Sharp Dohme. Tablet, Extended Release; Oral. Tablet; Oral ................. Alvogen. 250 mg; 500 mg; 750 mg. 7.5 mg; 200 mg ........... Tablet; Oral ................. Tablet; Oral ................. Janssen Research & Development, LLC. Abbvie, Inc. EQ 300 mg base; EQ 400 mg base; EQ 600 mg base. EQ 6.25 mg base; EQ 12.5 mg base. 1.1 gram ...................... Tablet; Oral ................. Abbvie, Inc. Tablet; Oral ................. Janssen Pharms. Tablets; Oral ............... 4 mg/5 mL; 5 mg/5 mL; 60 mg/5 mL. Solution; Oral .............. Valeant Pharms. International. Persion Pharms, LLC. 0.10% .......................... 400 mg; 800 mg .......... 5 mg; 10 mg; 20 mg; 100 mg. 30 mg; 60 mg; 90 mg EQ 250 mg base ......... Fmt 4703 Sfmt 4703 E:\FR\FM\22OCN1.SGM 22OCN1 Merck Sharp Dohme. Mylan. Mylan Specialty, L.P. Novartis. Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route NDA 022510 ... ABSTRAL .................... Fentanyl Citrate ........... Tablet; Sublingual ....... Sentynl Therapeutics, Inc. NDA 050011 ... PATHOCIL .................. Dicloxacillin Sodium .... Capsule; Oral .............. Wyeth-Ayerst Labs. NDA 204308 ... EPANED KIT ............... Enalapril Maleate ........ EQ 0.1 mg base; EQ 0.2 mg base; EQ 0.3 mg base; EQ 0.4 mg base; EQ 0.6 mg base; EQ 0.8 mg base. EQ 250 mg base; EQ 500 mg base. 1 mg/mL ...................... For Solution; Oral ........ NDA 207233 ... VIVLODEX .................. Meloxicam ................... 5 mg; 10 mg ................ Capsule; Oral .............. Silvergate Pharms., Inc. Zyla. FDA has reviewed its records and, under § 314.161, has determined that the drug products listed were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The Discontinued Drug Product List identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs listed are unaffected by the discontinued marketing of the products subject to those NDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. 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: October 19, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23084 Filed 10–21–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–1037] Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 Abbreviated New Drug Applications Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. AGENCY: lotter on DSK11XQN23PROD with NOTICES1 58675 The Food and Drug Administration (FDA or Agency) is withdrawing approval of 216 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have SUMMARY: VerDate Sep<11>2014 18:27 Oct 21, 2021 Jkt 256001 repeatedly failed to submit required annual reports for those ANDAs. DATES: Approval is withdrawn as of November 22, 2021. FOR FURTHER INFORMATION CONTACT: James Hanratty, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993–0002, 240– 402–4718, James.Hanratty@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The holders of an approved application to market a new drug for human use are required to submit annual reports to FDA concerning their approved application in accordance with §§ 314.81 and 314.98 (21 CFR 314.81 and 314.98). In the Federal Register of January 9, 2020 (85 FR 1160), FDA published a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of 249 ANDAs because the holders of those ANDAs had repeatedly failed to submit the required annual reports for those ANDAs (‘‘Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 Abbreviated New Drug Applications; Opportunity for a Hearing’’).1 The holder of ANDA 085882, ANDA 086262, and ANDA 0866263 responded to the NOOH and requested a hearing. The remaining holders of those ANDAs did not respond to the NOOH. Failure to file a written notice of participation and request for hearing as required by § 314.200 constitutes an election by those holders of the ANDAs not to make use of the opportunity for a hearing concerning the proposal to withdraw approval of their ANDAs and a waiver of any contentions concerning the legal status of the drug products. Therefore, FDA is withdrawing approval of the 216 applications listed in table 1. I. Annual Reports Submitted In response to the NOOH, one firm requested a hearing and had previously 1 85 FR 1160, published on January 9, 2020, incorrectly listed 249 as the number of the ANDAs FDA proposed to withdrawal. 85 FR 1160 listed 248 ANDAs in the table included in the notice. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Applicant submitted an annual report for each of its three ANDAs. Therefore, FDA rescinds its proposal to withdraw approval of the following three ANDAs: Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY 10920: • ANDA 085882, DUVOID (bethanechol chloride) Tablets, 50 milligrams (mg) • ANDA 086262, DUVOID (bethanechol chloride) Tablets, 10 mg • ANDA 086263, DUVOID (bethanechol chloride) Tablets, 25 mg Another three firms notified the Agency that they had submitted an annual report for each of its ANDAs listed in the NOOH. Therefore, FDA rescinds its proposal to withdraw approval of the following eight ANDAs: Jerome Stevens Pharmaceuticals Inc., 60 DaVinci Dr., Bohemia, NY 11716: • ANDA 062869, CEPHALEXIN Capsules USP, EQ 500 mg base • ANDA 062870, CEPHALEXIN Capsules USP, EQ 250 mg base • ANDA 074988, ASPIRIN, CAFFEINE, AND ORPHENADRINE CITRATE Tablets, 385 mg/30 mg/25 mg, and 770 mg/60 mg/50 mg • ANDA 081145, ASPIRIN AND METHOCARBAMOL Tablets, 325 mg/ 400 mg MIPS Cyclotron and Radiochemistry Facility, 1201 Welch Rd., Rm. PS049, Stanford, CA 94305: • ANDA 204472, FLUDEOXYGLUCOSE F–18 Injection USP, 20–300 millicuries (mCi)/milliliters (mL) • ANDA 204517, SODIUM FLUORIDE F–18 Injection, 10–200 mCi/mL • ANDA 204535, AMMONIA N–13 Injection USP, 3.75–37.5 mCi/mL Milex Products, Inc., 5915 Northwest Hwy., Chicago, IL 60631: • ANDA 072196, MILOPHENE (clomiphene citrate) Tablets, 50 mg II. Previously Consolidated Application Sandoz, Inc., 4700 Eon Dr., Wilson, NC 27893, notified the Agency that ANDA 084631, QUINIDINE SULFATE Tablets USP, 200 mg, had previously been consolidated with ANDA 088072. Therefore, FDA rescinds its proposal to withdraw approval of this ANDA. E:\FR\FM\22OCN1.SGM 22OCN1

Agencies

[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58674-58675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23084]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1038]


Determination That ROBAXIN and ROBAXIN-750 (Methocarbamol), Oral 
Tablets, 500 Milligrams and 750 Milligrams, and Other Drug Products, 
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 the drug products listed in this document 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 the products as long as 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, 
[email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of 
an ANDA to market a generic version of a previously approved drug 
product. To obtain approval, the ANDA applicant must show, among other 
things, that the generic drug product: (1) Has the same active 
ingredient(s), dosage form, route of administration, strength, 
conditions of use, and (with certain exceptions) labeling as the listed 
drug, which is a version of the drug that was previously approved and 
(2) is bioequivalent to the listed drug. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act 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 
generally known as the ``Orange Book.'' Under FDA regulations, a drug 
is 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).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness: (1) Before an ANDA that refers to that listed 
drug may be approved, (2) whenever a listed drug is voluntarily 
withdrawn from sale and ANDAs that refer to the listed drug have been 
approved, and (3) when a person petitions for such a determination 
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if 
FDA determines that a listed drug was withdrawn from sale for safety or 
effectiveness reasons, the Agency will initiate proceedings that could 
result in the withdrawal of approval of the ANDAs that refer to the 
listed drug.
    FDA has become aware that the drug products listed in the table are 
no longer being marketed.

----------------------------------------------------------------------------------------------------------------
                                               Active                           Dosage form/
   Application No.        Drug name        ingredient(s)       Strength(s)          route           Applicant
----------------------------------------------------------------------------------------------------------------
NDA 011011..........  ROBAXIN; ROBAXIN-  Methocarbamol....  500 milligrams    Tablet; Oral....  Auxilium
                       750.                                  (mg); 750 mg.                       Pharmaceuticals
                                                                                                 LLC.
NDA 018704..........  LOPRESSOR........  Metoprolol         1 mg/milliliter   Injectable;       Novartis.
                                          Tartrate.          (mL).             Injection.
NDA 018917..........  SECTRAL..........  Acebutolol         Equivalent to     Capsule; Oral...  Promius Pharma,
                                          Hydrochloride.     (EQ) 200 mg                         LLC.
                                                             base; EQ 400 mg
                                                             base.
NDA 019546..........  DYNACIRC.........  Isradipine.......  2.5 mg; 5 mg....  Capsule; Oral...  SmithKline
                                                                                                 Beecham.
NDA 019555..........  DIPROLENE AF.....  Betamethasone      EQ 0.05% base...  Cream,            Merck Sharp
                                          Dipropionate.                        Augmented;        Dohme.
                                                                               Topical.
NDA 019625..........  ELOCON...........  Mometasone         0.10%...........  Cream; Topical..  Merck Sharp
                                          Furoate.                                               Dohme.
NDA 020089..........  ZOVIRAX..........  Acyclovir........  400 mg; 800 mg..  Tablet; Oral....  Mylan.
NDA 020136..........  DEMADEX..........  Torsemide........  5 mg; 10 mg; 20   Tablet; Oral....  Mylan Specialty,
                                                             mg; 100 mg.                         L.P.
NDA 020198..........  ADALAT CC........  Nifedipine.......  30 mg; 60 mg; 90  Tablet, Extended  Alvogen.
                                                             mg.               Release; Oral.
NDA 020539..........  LAMISIL..........  Terbinafine        EQ 250 mg base..  Tablet; Oral....  Novartis.
                                          Hydrochloride.
NDA 020634..........  LEVAQUIN.........  Levofloxacin.....  250 mg; 500 mg;   Tablet; Oral....  Janssen Research
                                                             750 mg.                             & Development,
                                                                                                 LLC.
NDA 020716..........  VICOPROFEN.......  Hydrocodone        7.5 mg; 200 mg..  Tablet; Oral....  Abbvie, Inc.
                                          Bitartrate;
                                          Ibuprofen.
NDA 020738..........  TEVETEN..........  Eprosartan         EQ 300 mg base;   Tablet; Oral....  Abbvie, Inc.
                                          Mesylate.          EQ 400 mg base;
                                                             EQ 600 mg base.
NDA 021001..........  AXERT............  Almotriptan        EQ 6.25 mg base;  Tablet; Oral....  Janssen Pharms.
                                          Malate.            EQ 12.5 mg base.
NDA 022205..........  GIAZO............  Balsalazide        1.1 gram........  Tablets; Oral...  Valeant Pharms.
                                          Disodium.                                              International.
NDA 022439..........  ZUTRIPRO.........  Chlorpheniramine   4 mg/5 mL; 5 mg/  Solution; Oral..  Persion Pharms,
                                          Maleate,           5 mL; 60 mg/5                       LLC.
                                          Hydrocodone        mL.
                                          Bitartrate, and
                                          Pseudoephedrine
                                          Hydrochloride.

[[Page 58675]]

 
NDA 022510..........  ABSTRAL..........  Fentanyl Citrate.  EQ 0.1 mg base;   Tablet;           Sentynl
                                                             EQ 0.2 mg base;   Sublingual.       Therapeutics,
                                                             EQ 0.3 mg base;                     Inc.
                                                             EQ 0.4 mg base;
                                                             EQ 0.6 mg base;
                                                             EQ 0.8 mg base.
NDA 050011..........  PATHOCIL.........  Dicloxacillin      EQ 250 mg base;   Capsule; Oral...  Wyeth-Ayerst
                                          Sodium.            EQ 500 mg base.                     Labs.
NDA 204308..........  EPANED KIT.......  Enalapril Maleate  1 mg/mL.........  For Solution;     Silvergate
                                                                               Oral.             Pharms., Inc.
NDA 207233..........  VIVLODEX.........  Meloxicam........  5 mg; 10 mg.....  Capsule; Oral...  Zyla.
----------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed were not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the Agency will 
continue to list the drug products in the ``Discontinued Drug Product 
List'' section of the Orange Book. The Discontinued Drug Product List 
identifies, among other items, drug products that have been 
discontinued from marketing for reasons other than safety or 
effectiveness.
    Approved ANDAs that refer to the NDAs listed are unaffected by the 
discontinued marketing of the products subject to those NDAs. 
Additional ANDAs that refer to these products may also be approved by 
the Agency if they comply with relevant legal and regulatory 
requirements. 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: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23084 Filed 10-21-21; 8:45 am]
BILLING CODE 4164-01-P

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