[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Notices]
[Pages 75002-75003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24120]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4319]
Determination That CALCIUM DISODIUM VERSENATE (Edetate Calcium
Disodium) Injection, 200 Milligrams per Milliliter, 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Products Were Not Withdrawn From Sale for Reasons of Safety or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withdrawn from sale for reasons of safety or effectiveness.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
Application No. Drug name ingredient(s) Strength(s) Dosage form/route Applicant
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NDA 008922........ CALCIUM DISODIUM Edetate Calcium 200 Milligrams Injectable; Bausch Health
VERSENATE. Disodium. (mg)/Milliliter Injection. US, LLC.
(mL).
NDA 011722........ TENUATE.......... Diethylpropion 25 mg............ Tablet; Oral..... Nostrum Labs.,
Hydrochloride. Inc.
NDA 012546........ TENUATE DOSPAN... Diethylpropion 75 mg............ Tablets, Extended- Do.
Hydrochloride. Release; Oral.
NDA 019117........ FLUOCINONIDE..... Fluocinonide..... 0.05%............ Cream; Topical... Taro Pharms.
U.S.A., Inc.
NDA 019796........ ELOCON........... Mometasone 0.1%............. Lotion; Topical.. Organon, LLC.
Furoate.
NDA 020489........ ANDRODERM........ Testosterone..... 2 mg/24 hours; 4 Film, Extended AbbVie Inc.
mg/24 hours. Release;
Transdermal.
NDA 020884........ AGGRENOX......... Aspirin; 25 mg; 200 mg.... Capsule, Extended Boehringer
Dipyridamole. Release; Oral. Ingelheim
Pharms., Inc.
NDA 020903........ REBETOL.......... Ribavirin........ 200 mg........... Capsule; Oral.... Merck Sharp and
Dohme Corp.
NDA 020907........ ACTIVELLA........ Estradiol; 0.5 mg; 0.1 mg... Tablet; Oral..... Amneal Pharms.,
Norethindrone LLC.
Acetate.
NDA 020949........ ACCUNEB.......... Albuterol Sulfate Equivalent to Solution; Mylan Specialty
(EQ) 0.021% Inhalation. LP.
Base; EQ 0.042%
Base.
NDA 021022........ PENLAC........... Ciclopirox....... 8%............... Solution; Topical Valeant
International
Bermuda.
NDA 021449........ HEPSERA.......... Adefovir 10 mg............ Tablet; Oral..... Gilead Sciences,
Dipivoxil. Inc.
NDA 022052........ ZYFLO CR......... Zileuton......... 600 mg........... Tablet, Extended Chiesi USA, Inc.
Release; Oral.
NDA 022511........ VIMOVO........... Esomeprazole EQ 20 mg Base; Tablet, Delayed Horizon
Magnesium; 375 mg; EQ 20 mg Release; Oral. Medicines LLC.
Naproxen. Base; 500 mg.
NDA 022569........ LAZANDA.......... Fentanyl Citrate. EQ 0.1mg Base; EQ Spray, Metered; BTcP Pharma,
0.3 mg Base; EQ Nasal. LLC.
0.4 mg Base.
NDA 202788........ SUBSYS........... Fentanyl......... 0.1 mg; 0.2 mg; Spray; Sublingual Do.
0.4 mg; 0.6 mg;
0.8 mg; 1.2 mg;
1.6 mg.
NDA 213645........ DAPZURA RT....... Daptomycin....... 500 mg/Vial...... Powder; Baxter
Intravenous. Healthcare
Corp.
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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
[[Page 75003]]
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.
Dated: October 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24120 Filed 10-31-23; 8:45 am]
BILLING CODE 4164-01-P