The eRulemaking Program

11/01/2023 | Press release | Distributed by Public on 11/01/2023 06:50

Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness: Calcium Disodium Versenate (Edetate Calcium Disodium) Injection, 200 Milligrams Per Milliliter,[...]

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VERSENATE (Edetate Calcium Disodium) Injection, 200 Milligrams per Milliliter, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness


Food and Drug Administration, HHS.




The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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 § 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 008922 CALCIUM DISODIUM VERSENATE Edetate Calcium Disodium 200 Milligrams (mg)/Milliliter (mL) Injectable; Injection Bausch Health US, LLC.
NDA 011722 TENUATE Diethylpropion Hydrochloride 25 mg Tablet; Oral Nostrum Labs., Inc.
NDA 012546 TENUATE DOSPAN Diethylpropion Hydrochloride 75 mg Tablets, Extended-Release; Oral Do.
NDA 019117 FLUOCINONIDE Fluocinonide 0.05% Cream; Topical Taro Pharms. U.S.A., Inc.
NDA 019796 ELOCON Mometasone Furoate 0.1% Lotion; Topical Organon, LLC.
NDA 020489 ANDRODERM Testosterone 2 mg/24 hours; 4 mg/24 hours Film, Extended Release; Transdermal AbbVie Inc.
NDA 020884 AGGRENO X Aspirin; Dipyridamole 25 mg; 200 mg Capsule, Extended Release; Oral Boehringer Ingelheim Pharms., Inc.
NDA 020903 REBETOL Ribavirin 200 mg Capsule; Oral Merck Sharp and Dohme Corp.
NDA 020907 ACTIVELLA Estradiol; Norethindrone Acetate 0.5 mg; 0.1 mg Tablet; Oral Amneal Pharms., LLC.
NDA 020949 ACCUNEB Albuterol Sulfate Equivalent to (EQ) 0.021% Base; EQ 0.042% Base Solution; Inhalation Mylan Specialty LP.
NDA 021022 PENLAC Ciclopirox 8% Solution; Topical Valeant International Bermuda.
NDA 021449 HEPSERA Adefovir Dipivoxil 10 mg Tablet; Oral Gilead Sciences, Inc.
NDA 022052 ZYFLO CR Zileuton 600 mg Tablet, Extended Release; Oral Chiesi USA, Inc.
NDA 022511 VIMOVO Esomeprazole Magnesium; Naproxen EQ 20 mg Base; 375 mg; EQ 20 mg Base; 500 mg Tablet, Delayed Release; Oral Horizon Medicines LLC.
NDA 022569 LAZANDA Fentanyl Citrate EQ 0.1mg Base; EQ 0.3 mg Base; EQ 0.4 mg Base Spray, Metered; Nasal BTcP Pharma, LLC.
NDA 202788 SUBSYS Fentanyl 0.1 mg; 0.2 mg; 0.4 mg; 0.6 mg; 0.8 mg; 1.2 mg; 1.6 mg Spray; Sublingual Do.
NDA 213645 DAPZURA RT Daptomycin 500 mg/Vial Powder; Intravenous Baxter Healthcare Corp.

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 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]