11/01/2023 | Press release | Distributed by Public on 11/01/2023 06:50
Food and Drug Administration, HHS.
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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 as long as they meet relevant legal and regulatory requirements.
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].
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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30.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.