Determination That BUTISOL SODIUM (Butabarbital Sodium) Oral Tablets, 15 Milligrams, 50 Milligrams, and 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 66994-66995 [2020-23300]

Download as PDF 66994 Federal Register / Vol. 85, No. 204 / Wednesday, October 21, 2020 / Notices 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–2032] 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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 refer to the products if they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation SUMMARY: Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant ......... ......... ......... ......... BUTISOL SODIUM ... SECONAL SODIUM VELBAN .................... PAVULON ................. 15 mg; 50 mg; 100 mg ... 50 mg/Milliliter (mL) ......... 10 mg/Vial ....................... 1 mg/mL; 2 mg/mL .......... Tablet; Oral ............... Injectable; Injection ... Injectable; Injection ... Injectable; Injection ... NDA 017919 ......... 0.035 mg;1 mg ................ Tablet; Oral-28 .......... NDA 018554 ......... ORTHO–NOVUM 1/ 35–28. EULEXIN .................. Butabarbital Sodium Secobarbital Sodium Vinblastine Sulfate .... Pancuronium Bromide. Ethinyl Estradiol; Norethindrone. Flutamide .................. 125 mg ............................ Capsule; Oral ............ NDA 019151 ......... RYTHMOL ................ 150 mg, 225 mg, 300 mg Tablet; Oral ............... Mylan Specialty, L.P. Eli Lilly and Co. Eli Lilly and Co. Schering-Plough Corp. Janssen Pharmaceuticals, Inc. Schering-Plough Corp. GlaxoSmithKline. NDA 019579 ......... TERAZOL 7 .............. 0.4% ................................ Cream; Vaginal ......... NDA 019599 ......... NAFTIN ..................... 1% ................................... Cream; Topical ......... NDA 019653 ......... ORTHO CYCLEN–28 0.035 mg; 0.25 mg .......... Tablet; Oral-28 .......... NDA 019716 ......... DIPROLENE ............. EQ 0.05% Base .............. NDA 019964 ......... TERAZOL 3 .............. Naftifine Hydrochloride. Ethinyl Estradiol; Norgestimate. Betamethasone Dipropionate. Terconazole .............. Lotion, Augmented; Topical. Cream; Vaginal ......... NDA 020313 ......... MIACALCIN .............. Calcitonin Salmon ..... NDA 020388 ......... NAVELBINE .............. NDA 020413 ......... NDA 020741 ......... NDA 020872 ......... NDA NDA NDA NDA khammond on DSKJM1Z7X2PROD with NOTICES 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 approved 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,’’ SUPPLEMENTARY INFORMATION: Determination That BUTISOL SODIUM (Butabarbital Sodium) Oral Tablets, 15 Milligrams, 50 Milligrams, and 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness 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. 000793 007392 012665 017015 Propafenone Hydrochloride. Terconazole .............. 0.8% ................................ Vinorelbine Tartrate .. 200 International Units/ Spray. EQ 10 mg Base/mL ........ Injectable; Injection ... ZERIT ....................... PRANDIN .................. Stavudine .................. Repaglinide ............... 1 mg/mL .......................... 0.5 mg; 1 mg; 2 mg ........ For Solution; Oral ..... Tablet; Oral ............... Fexofenadine Hydrochloride. 30 mg .............................. Tablet; Oral ............... NDA 021071 ......... CHILDREN’S ALLEGRA ALLERGY. AVANDIA .................. EQ 8 mg Base ................ Tablets; Oral ............. NDA 021235 ......... PROZAC WEEKLY ... Rosiglitazone Maleate. Fluoxetine Hydrochloride. EQ 90 mg/Base ............... Delayed-Release Capsules; Oral. VerDate Sep<11>2014 16:58 Oct 20, 2020 Jkt 253001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Metered Spray; Nasal E:\FR\FM\21OCN1.SGM 21OCN1 Janssen Pharmaceuticals, Inc. Sebela Ireland Limited. Janssen Pharmaceuticals, Inc. Merck Sharp & Dohme Corp. Janssen Pharmaceuticals, Inc. Mylan Ireland Limited. Pierre Fabre Medicament. Bristol-Myers Squibb. Gemini Laboratories, LLC. Sanofi-Aventis U.S., LLC. SB Pharmco Puerto Rico, Inc. Eli Lilly and Co. 66995 Federal Register / Vol. 85, No. 204 / Wednesday, October 21, 2020 / Notices Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route NDA 021909 ......... NDA 022291 ......... NDA 022362 ......... PROMACTA ............. WELCHOL ................ EQ 100 mg Acid .............. 1.875 g/Packet ................ Tablet, Orally Disintegrating; Oral. Tablet, Orally Disintegrating; Oral. Tablet; Oral ............... For Suspension; Oral Sanofi-Aventis U.S., LLC. Bausch Health US, LLC. Novartis. Daiichi Sankyo. NDA 022396 ......... DYLOJECT ............... Fexofenadine Hydrochloride. Metoclopramide Hydrochloride. Eltrombopag Olamine Colesevelam Hydrochloride. Diclofenac Sodium .... 30 mg .............................. NDA 022246 ......... CHILDREN’S ALLEGRA HIVES. METOZOLV ODT ..... 37.5 mg/mL (37.5 mg/mL) Solution; Intravenous NDA 050368 ......... NDA 050587 ......... ILOTYCIN ................. PRIMAXIN ................ Ointment; Ophthalmic Powder; Intravenous NDA 201373 ......... CHILDREN’S ALLEGRA HIVES. NARCAN ................... 0.5% ................................ EQ 250 mg Base/Vial; 250 mg/Vial. 30 mg/5 mL ..................... Javelin Pharmaceuticals, Inc. Eli Lilly and Co. Merck & Co., Inc. 2 mg/Spray ...................... Spray, Metered; Nasal. NDA 208411 ......... Erythromycin ............. Cilastatin Sodium; Imipenem. Fexofenadine Hydrochloride. Naloxone Hydrochloride. 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 and ANDAs listed are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. 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 16, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–23300 Filed 10–20–20; 8:45 am] khammond on DSKJM1Z7X2PROD with NOTICES BILLING CODE 4164–01–P VerDate Sep<11>2014 16:58 Oct 20, 2020 Jkt 253001 EQ 5 mg Base ................ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3771] Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.’’ Forms FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics, are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on postmarketing requirements (PMRs) and postmarketing commitments (PMCs) in a consistent format. Forms FDA 3988 and 3989 are published in draft form in Appendix A and B of the draft guidance for comment and are not intended to be used until the forms are finalized. The forms were developed, in part, in response to the recommendations from the Government Accountability Office (GAO) and the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) regarding the need for comparable information across annual status reports (ASRs) on PMRs and SUMMARY: PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 Suspension; Oral ...... Applicant Sanofi-Aventis U.S., LLC. Adapt Pharma. PMCs, to eliminate manual data entry, and to enhance FDA’s ability to track PMRs and PMCs. These forms are expected to result in improved accuracy and timeliness of FDA’s identification and review of those submissions containing information on PMRs and PMCs. This draft guidance covers the purpose of each form, when to use these forms, and how to submit these forms. The draft guidance also explains where applicants will be able to find the forms and instructions for their completion once the forms and instructions are finalized. Submit either electronic or written comments on the draft guidance by December 21, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit either electronic or written comments on the collection of information set forth in this document by December 21, 2020. ADDRESSES: You may submit comments on any guidance at any time as follows: DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that E:\FR\FM\21OCN1.SGM 21OCN1

Agencies

[Federal Register Volume 85, Number 204 (Wednesday, October 21, 2020)]
[Notices]
[Pages 66994-66995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23300]



[[Page 66994]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2032]


Determination That BUTISOL SODIUM (Butabarbital Sodium) Oral 
Tablets, 15 Milligrams, 50 Milligrams, and 100 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 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, 
[email protected].

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 approved 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 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 000793.............  BUTISOL SODIUM..  Butabarbital      15 mg; 50 mg;     Tablet; Oral....  Mylan
                                            Sodium.           100 mg.                             Specialty,
                                                                                                  L.P.
NDA 007392.............  SECONAL SODIUM..  Secobarbital      50 mg/Milliliter  Injectable;       Eli Lilly and
                                            Sodium.           (mL).             Injection.        Co.
NDA 012665.............  VELBAN..........  Vinblastine       10 mg/Vial......  Injectable;       Eli Lilly and
                                            Sulfate.                            Injection.        Co.
NDA 017015.............  PAVULON.........  Pancuronium       1 mg/mL; 2 mg/mL  Injectable;       Schering-Plough
                                            Bromide.                            Injection.        Corp.
NDA 017919.............  ORTHO-NOVUM 1/35- Ethinyl           0.035 mg;1 mg...  Tablet; Oral-28.  Janssen
                          28.               Estradiol;                                            Pharmaceutical
                                            Norethindrone.                                        s, Inc.
NDA 018554.............  EULEXIN.........  Flutamide.......  125 mg..........  Capsule; Oral...  Schering-Plough
                                                                                                  Corp.
NDA 019151.............  RYTHMOL.........  Propafenone       150 mg, 225 mg,   Tablet; Oral....  GlaxoSmithKline
                                            Hydrochloride.    300 mg.                             .
NDA 019579.............  TERAZOL 7.......  Terconazole.....  0.4%............  Cream; Vaginal..  Janssen
                                                                                                  Pharmaceutical
                                                                                                  s, Inc.
NDA 019599.............  NAFTIN..........  Naftifine         1%..............  Cream; Topical..  Sebela Ireland
                                            Hydrochloride.                                        Limited.
NDA 019653.............  ORTHO CYCLEN-28.  Ethinyl           0.035 mg; 0.25    Tablet; Oral-28.  Janssen
                                            Estradiol;        mg.                                 Pharmaceutical
                                            Norgestimate.                                         s, Inc.
NDA 019716.............  DIPROLENE.......  Betamethasone     EQ 0.05% Base...  Lotion,           Merck Sharp &
                                            Dipropionate.                       Augmented;        Dohme Corp.
                                                                                Topical.
NDA 019964.............  TERAZOL 3.......  Terconazole.....  0.8%............  Cream; Vaginal..  Janssen
                                                                                                  Pharmaceutical
                                                                                                  s, Inc.
NDA 020313.............  MIACALCIN.......  Calcitonin        200               Metered Spray;    Mylan Ireland
                                            Salmon.           International     Nasal.            Limited.
                                                              Units/Spray.
NDA 020388.............  NAVELBINE.......  Vinorelbine       EQ 10 mg Base/mL  Injectable;       Pierre Fabre
                                            Tartrate.                           Injection.        Medicament.
NDA 020413.............  ZERIT...........  Stavudine.......  1 mg/mL.........  For Solution;     Bristol-Myers
                                                                                Oral.             Squibb.
NDA 020741.............  PRANDIN.........  Repaglinide.....  0.5 mg; 1 mg; 2   Tablet; Oral....  Gemini
                                                              mg.                                 Laboratories,
                                                                                                  LLC.
NDA 020872.............  CHILDREN'S        Fexofenadine      30 mg...........  Tablet; Oral....  Sanofi-Aventis
                          ALLEGRA ALLERGY.  Hydrochloride.                                        U.S., LLC.
NDA 021071.............  AVANDIA.........  Rosiglitazone     EQ 8 mg Base....  Tablets; Oral...  SB Pharmco
                                            Maleate.                                              Puerto Rico,
                                                                                                  Inc.
NDA 021235.............  PROZAC WEEKLY...  Fluoxetine        EQ 90 mg/Base...  Delayed-Release   Eli Lilly and
                                            Hydrochloride.                      Capsules; Oral.   Co.

[[Page 66995]]

 
NDA 021909.............  CHILDREN'S        Fexofenadine      30 mg...........  Tablet, Orally    Sanofi-Aventis
                          ALLEGRA HIVES.    Hydrochloride.                      Disintegrating;   U.S., LLC.
                                                                                Oral.
NDA 022246.............  METOZOLV ODT....  Metoclopramide    EQ 5 mg Base....  Tablet, Orally    Bausch Health
                                            Hydrochloride.                      Disintegrating;   US, LLC.
                                                                                Oral.
NDA 022291.............  PROMACTA........  Eltrombopag       EQ 100 mg Acid..  Tablet; Oral....  Novartis.
                                            Olamine.
NDA 022362.............  WELCHOL.........  Colesevelam       1.875 g/Packet..  For Suspension;   Daiichi Sankyo.
                                            Hydrochloride.                      Oral.
NDA 022396.............  DYLOJECT........  Diclofenac        37.5 mg/mL (37.5  Solution;         Javelin
                                            Sodium.           mg/mL).           Intravenous.      Pharmaceutical
                                                                                                  s, Inc.
NDA 050368.............  ILOTYCIN........  Erythromycin....  0.5%............  Ointment;         Eli Lilly and
                                                                                Ophthalmic.       Co.
NDA 050587.............  PRIMAXIN........  Cilastatin        EQ 250 mg Base/   Powder;           Merck & Co.,
                                            Sodium;           Vial; 250 mg/     Intravenous.      Inc.
                                            Imipenem.         Vial.
NDA 201373.............  CHILDREN'S        Fexofenadine      30 mg/5 mL......  Suspension; Oral  Sanofi-Aventis
                          ALLEGRA HIVES.    Hydrochloride.                                        U.S., LLC.
NDA 208411.............  NARCAN..........  Naloxone          2 mg/Spray......  Spray, Metered;   Adapt Pharma.
                                            Hydrochloride.                      Nasal.
----------------------------------------------------------------------------------------------------------------

    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 and ANDAs listed are 
unaffected by the discontinued marketing of the products subject to 
those NDAs and ANDAs. 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 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23300 Filed 10-20-20; 8:45 am]
BILLING CODE 4164-01-P

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