[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]


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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Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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.

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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withdrawn from sale for reasons of safety or effectiveness.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.

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                                               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.
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    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