Notice2026-11429
Determination That Protamine Sulfate (Protamine Sulfate) Intravenous; Solution, 50 Milligrams/5 Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Published
June 8, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 91 Issue 109 (Monday, June 8, 2026)</title>
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[Federal Register Volume 91, Number 109 (Monday, June 8, 2026)]
[Notices]
[Pages 34634-34635]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11429]
[[Page 34634]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-5817]
Determination That Protamine Sulfate (Protamine Sulfate)
Intravenous; Solution, 50 Milligrams/5 Milliliters, 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Products Were Not Withdrawn From Sale for Reasons of Safety or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withdrawn from sale for reasons of safety or effectiveness.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,
<a href="/cdn-cgi/l/email-protection#2d7e594c4e5403664c43486d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="085b7c696b71264369666d486e6c692660607b266f677e">[email protected]</span></a>.
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 table 1 are
no longer being marketed.
Table 1--Drug Products Not Withdrawn From Sale for Reasons of Safety or Effectiveness
----------------------------------------------------------------------------------------------------------------
Active Dosage form/
Application No. Drug name ingredient(s) Strength(s) route Applicant
----------------------------------------------------------------------------------------------------------------
NDA 006460.......... PROTAMINE SULFATE Protamine Sulfate 50 Milligrams Solution; Eli Lilly and
(mg)/5 Intravenous. Co.
Milliliters
(mL) (10 mg/mL).
NDA 011719.......... METHOTREXATE Methotrexate Equal to (EQ) Injectable; Hospira, Inc.
SODIUM; Sodium. 2.5 mg Base/mL; Injection.
METHOTREXTATE EQ 20 mg Base/2
LPF AND mL (EQ 10 mg
METHOTREXATE Base/mL); EQ 20
PRESERVATIVE mg Base/Vial;
FREE. EQ 25 mg Base/
mL; EQ 25 mg
Base/mL; EQ 2.5
grams (g) Base/
100 mL (EQ 25
mg Base/mL); EQ
50 mg Base/
Vial; EQ 100 mg
Base/Vial; EQ
1g Base/Vial.
NDA 012250.......... CARBOCAINE....... Mepivacaine 1%; 1.5%; 2%.... Injectable; Hospira, Inc.
Hydrochloride. Injection.
NDA 016909.......... LIDEX............ Fluocinonide..... 0.05%........... Ointment; Alvogen, Inc.
Topical.
NDA 017010.......... DESONIDE......... Desonide......... 0.05%........... Cream; Topical.. Padagis LLC.
NDA 017735.......... MODICON 28....... Ethinyl 0.035 mg; 0.5 mg Tablet; Oral-28. Janssen
Estradiol; Pharmaceuticals
Norethindrone. , Inc.
NDA 018337.......... ACETAMINOPHEN.... Acetaminophen.... 650 mg.......... Suppository; Taro
Rectal. Pharmaceutical
Industries Ltd.
NDA 019260.......... PSORCON.......... Diflorasone 0.05%........... Ointment; Pfizer Inc.
Diacetate. Topical.
NDA 019487 P001..... IMODIUM A-D...... Loperamide 1 mg/5 mL....... Solution; Oral.. Kenvue Brands
Hydrochloride. LLC.
NDA 020021.......... SUDAFED 24 HOUR.. Pseudoephedrine 240 mg.......... Tablet, Extended Kenvue Brands
Hydrochloride. Release; Oral. LLC.
NDA 020449.......... TAXOTERE......... Docetaxel........ 20 mg/mL (20 mg/ Injectable; Sanofi-Aventis
mL); 80 mg/4 mL Injection. U.S. LLC.
(20 mg/mL).
NDA 020497.......... FARESTON......... Toremifene EQ 60 mg Base... Tablet; Oral.... Kyowa Kirin.
Citrate.
NDA 020657.......... SPORANOX......... Itraconazole..... 10 mg/mL........ Solution; Oral.. Janssen
Pharmaceuticals
.
NDA 020710.......... PAXIL............ Paroxetine EQ 10 mg Base/5 Suspension; Oral Apotex Inc.
Hydrochloride. mL.
NDA 020747.......... ACTIQ............ Fentanyl Citrate. EQ 0.2 mg Base; Troche/Lozenge; Cephalon, LLC.
EQ 0.4 mg Base; Transmucosal.
EQ 0.6 mg Base;
eq 0.8 mg Base;
EQ 1.2 mg Base;
EQ 1.6 mg Base.
NDA 020757.......... AVAPRO........... Irbesartan....... 75 mg........... Tablet; Oral.... Sanofi-Aventis
U.S. LLC.
NDA 021065.......... FEMHRT........... Ethinyl 0.0025 mg; 0.5 Tablet; Oral.... Allergan
Estradiol; mg. Pharmaceuticals
Norethindrone International
Acetate. Ltd.
NDA 021087.......... TAMIFLU.......... Oseltamivir EQ 30 mg Base; Capsule; Oral... Roche.
Phosphate. EQ 45 mg Base.
[[Page 34635]]
NDA 021227.......... CANCIDAS......... Caspofungin 50 mg/Vial; 70 Powder; Merck Sharp &
Acetate. mg/Vial. Intravenous. Dohme.
NDA 021506.......... MYCAMINE......... Micafungin Sodium EQ 50 mg Base/ Injectable; Astellas Pharma
Vial; EQ 100 mg Intravenous. US Inc.
Base/Vial.
NDA 021520.......... SYMBYAX.......... Fluoxetine EQ 25 mg Base; Capsule; Oral... Eli Lilly and
Hydrochloride; EQ 3 mg Base; Co.
Olanzapine. EQ 25 mg Base;
EQ 6 mg Base;
EQ 25 mg Base;
EQ 12 mg Base;
EQ 50 mg Base;
EQ 6 mg Base;
EQ 50 mg Base;
EQ 12 mg Base.
NDA 021947.......... FENTORA.......... Fentanyl Citrate. EQ 0.1 mg Base; Tablet; Buccal, Cephalon, LLC.
EQ 0.2 mg Base; Sublingual.
EQ 0.4 mg Base;
EQ 0.6 mg Base;
EQ 0.8 mg Base.
NDA 022076.......... LOCOID........... Hydrocortisone 0.1%............ Lotion; Topical. Bausch Health.
Butyrate.
NDA 022116.......... LEXIVA........... Fosamprenavir EQ 50 mg Base/mL Suspension; Oral ViiV Healthcare.
Calcium.
NDA 022224.......... TRILIPIX......... Choline EQ 45 mg Capsule, Delayed AbbVie Inc.
Fenofibrate. Fenofibric Release; Oral.
Acid; EQ 135 mg
Fenofibric Acid.
NDA 022525.......... NAMENDA XR....... Memantine 14 mg; 21 mg; 28 Capsule, AbbVie Inc.
Hydrochloride. mg. Extended
Release; Oral.
NDA 022573.......... NORETHINDRONE AND Ethinyl 0.025 mg; 0.8 mg Tablet, Teva Branded
ETHINYL Estradiol; Chewable; Oral. Pharmaceutical
ESTRADIOL AND Norethindrone. Products R&D,
FERROUS FUMARATE. Inc.
NDA 050007.......... VIBRAMYCIN....... Doxycycline EQ 100 mg Base.. Capsule; Oral... Pfizer, Inc.
Hyclate.
NDA 050537.......... CLEOCIN.......... Clindamycin EQ 1% Base...... Swab; Topical... Pfizer, Inc.
Phosphate.
ANDA 080615......... DIMENHYDRINATE... Dimenhydrinate... 50 mg/mL........ Injectable;
Injection.
ANDA 084499......... ESTRACE.......... Estradiol........ 1 mg............ Tablet; Oral.... Bristol Myers
Squibb.
ANDA 084500......... ESTRACE.......... Estradiol........ 2 mg............ Tablet; Oral.... Bristol Myers
Squibb.
ANDA 088023......... ADIPEX-P......... Phentermine 37.5 mg......... Capsule; Oral... Teva USA.
Hydrochloride.
NDA 204300.......... VAZCULEP......... Phenylephrine 10 mg/mL (10 mg/ Solution; Exela Pharma
Hydrochloride. mL); 50 mg/5 Intravenous. Sciences.
mL; 100 mg/10
mL.
NDA 204412.......... DELZICOL......... Mesalamine....... 400 mg.......... Capsule, Delayed AbbVie Inc.
Release; Oral.
NDA 208418.......... CALCIUM GLUCONATE Calcium Gluconate 1 g/50 mL; 2 g/ Solution; Fresenius Kabi
100mL. Intravenous. USA, LLC.
NDA 209091.......... QTERN............ Dapagliflozin; 5 mg; EQ 5 mg Tablet; Oral.... AstraZeneca AB.
Saxagliptin Base 10 mg; EQ
Hydrochloride. 5 mg Base.
----------------------------------------------------------------------------------------------------------------
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 drug products listed are
unaffected by the discontinued marketing of the products subject to
these applications. 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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-11429 Filed 6-5-26; 8:45 am]
BILLING CODE 4164-01-P
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