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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 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, Stacy.Kane@fda.hhs.gov.
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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30.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 017604 | NALFON | Fenoprofen Calcium | Equivalent to (EQ) 300 Milligrams (mg) Base | Capsule; Oral | Xspire Pharma. |
NDA 017087 | ETHRANE | Enflurane | 99.9% | Liquid; Inhalation | Baxter Healthcare Corp. |
NDA 018801 | STERILE WATER FOR INJECTION | Sterile Water For Injection | 100% (1 Milliliter (mL)); 100% (5.2 mL) | Liquid; N/A | Hospira, A Pfizer Company. |
NDA 019152 | CALAN SR | Verapamil Hydrochloride | 120 mg; 180 mg, 240 mg | Tablet, Extended Release; Oral | Pfizer Inc. |
NDA 019885 | ACCUPRIL | Quinapril Hydrochloride | EQ 5 mg Base; EQ 10 mg Base; EQ 20 mg Base; EQ 40 mg Base | Tablet; Oral | Pfizer Pharmaceuticals Ltd. |
NDA 019941 | EMLA | Lidocaine; Prilocaine | 2.5%; 2.5% | Cream; Topical | Teva Branded Pharmaceutical Products R & D Inc. |
NDA 020105 | TRIOSTAT | Liothyronine Sodium | EQ 0.01 mg Base/mL | Injectable; Injection | Par Sterile Products, LLC. |
NDA 020125 | ACCURETIC | Hydrochlorothiazide; Quinapril Hydrochloride | 12.5 mg, EQ 10 mg Base; 12.5 mg, EQ 20 mg Base; 25 mg, EQ 20 mg Base | Tablet; Oral | Pfizer Pharmaceuticals Ltd. |
NDA 020406 | PREVACID | Lansoprazole | 15 mg | Capsule, Delayed Release Pellets; Oral | Takeda Pharmaceuticals USA, Inc. |
NDA 020666 | ALBENZA | Albendazole | 200 mg | Tablet; Oral | Impax Laboratories Inc. |
NDA 020723 | ALDARA | Imiquimod | 5% | Cream; Topical | Bausch Health US LLC. |
NDA 020972 | SUSTIVA | Efavirenz | 50 mg; 200 mg | Capsule; Oral | Bristol Myers Squibb Co. |
NDA 021009 | ALOCRIL | Nedocromil Sodium | 2% | Solution/Drops; Ophthalmic | Allergan Inc. |
NDA 021526 | RANEXA | Ranolazine | 500 mg; 1 g | Tablet, Extended Release; Oral | Menarini International Operations Luxembourg SA. |
NDA 021565 | ELESTAT | Epinastine Hydrochloride | 0.05% | Solution/Drops; Ophthalmic | Allergan Inc. |
NDA 021775 | ENTEREG | Alvimopan | 12 mg | Capsule; Oral | Cubist Pharmaceuticals, Inc. |
NDA 021790 | DACOGEN | Decitabine | 50 mg/Vial | Injectable; Intravenous | Otsuka Pharmaceutical Co., Ltd. |
NDA 050095 | CAPASTAT SULFATE | Capreomycin Sulfate | EQ 1 g Base/Vial | Injectable; Injection | Epic Pharma, LLC. |
NDA 050795 | DORYX | Doxycycline Hyclate | EQ 50 mg Base; EQ 100 mg Base; EQ 120 mg Base | Tablet, Delayed Release; Oral | Mayne Pharma International Pty Ltd. |
NDA 050801 | EVOCLIN | Clindamycin Phosphate | 1% | Aerosol, Foam; Topical | Mylan Pharmaceuticals Inc. |
NDA 200179 | STAXYN | Vardenafil Hydrochloride | 10 mg | Tablet, Orally Disintegrating; Oral | Bayer Healthcare Pharmaceuticals Inc. |
NDA 202515 | MORPHINE SULFATE | Morphine Sulfate | 15 mg/mL | Injectable; Injection | Hospira, A Pfizer Company. |
NDA 203667 | MINASTRIN 24 FE | Ethinyl Estradiol; Norethindrone Acetate | 0.02mg, 1mg | Tablet; Oral | Allergan Pharmaceuticals International, Ltd. |
NDA 210854 | XOFLUZA | Baloxavir Marboxil | 20 mg | Tablet; Oral | Genentech, Inc. |
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: April 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07494 Filed 4-8-24; 8:45 am]
BILLING CODE 4164-01-P