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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30.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 011011 | ROBAXIN; ROBAXIN-750 | Methocarbamol | 500 milligrams (mg); 750 mg | Tablet; Oral | Auxilium Pharmaceuticals LLC. |
NDA 018704 | LOPRESSOR | Metoprolol Tartrate | 1 mg/milliliter (mL) | Injectable; Injection | Novartis. |
NDA 018917 | SECTRAL | Acebutolol Hydrochloride | Equivalent to (EQ) 200 mg base; EQ 400 mg base | Capsule; Oral | Promius Pharma, LLC. |
NDA 019546 | DYNACIRC | Isradipine | 2.5 mg; 5 mg | Capsule; Oral | SmithKline Beecham. |
NDA 019555 | DIPROLENE AF | Betamethasone Dipropionate | EQ 0.05% base | Cream, Augmented; Topical | Merck Sharp Dohme. |
NDA 019625 | ELOCON | Mometasone Furoate | 0.10% | Cream; Topical | Merck Sharp Dohme. |
NDA 020089 | ZOVIRAX | Acyclovir | 400 mg; 800 mg | Tablet; Oral | Mylan. |
NDA 020136 | DEMADEX | Torsemide | 5 mg; 10 mg; 20 mg; 100 mg | Tablet; Oral | Mylan Specialty, L.P. |
NDA 020198 | ADALAT CC | Nifedipine | 30 mg; 60 mg; 90 mg | Tablet, Extended Release; Oral | Alvogen. |
NDA 020539 | LAMISIL | Terbinafine Hydrochloride | EQ 250 mg base | Tablet; Oral | Novartis. |
NDA 020634 | LEVAQUIN | Levofloxacin | 250 mg; 500 mg; 750 mg | Tablet; Oral | Janssen Research & Development, LLC. |
NDA 020716 | VICOPROFEN | Hydrocodone Bitartrate; Ibuprofen | 7.5 mg; 200 mg | Tablet; Oral | Abbvie, Inc. |
NDA 020738 | TEVETEN | Eprosartan Mesylate | EQ 300 mg base; EQ 400 mg base; EQ 600 mg base | Tablet; Oral | Abbvie, Inc. |
NDA 021001 | AXERT | Almotriptan Malate | EQ 6.25 mg base; EQ 12.5 mg base | Tablet; Oral | Janssen Pharms. |
NDA 022205 | GIAZO | Balsalazide Disodium | 1.1 gram | Tablets; Oral | Valeant Pharms. International. |
NDA 022439 | ZUTRIPRO | Chlorpheniramine Maleate, Hydrocodone Bitartrate, and Pseudoephedrine Hydrochloride | 4 mg/5 mL; 5 mg/5 mL; 60 mg/5 mL | Solution; Oral | Persion Pharms, LLC. |
NDA 022510 | ABSTRAL | Fentanyl Citrate | EQ 0.1 mg base; EQ 0.2 mg base; EQ 0.3 mg base; EQ 0.4 mg base; EQ 0.6 mg base; EQ 0.8 mg base | Tablet; Sublingual | Sentynl Therapeutics, Inc. |
NDA 050011 | PATHOCIL | Dicloxacillin Sodium | EQ 250 mg base; EQ 500 mg base | Capsule; Oral | Wyeth-Ayerst Labs. |
NDA 204308 | EPANED KIT | Enalapril Maleate | 1 mg/mL | For Solution; Oral | Silvergate Pharms., Inc. |
NDA 207233 | VIVLODEX | Meloxicam | 5 mg; 10 mg | Capsule; Oral | Zyla. |
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 NDAs listed are unaffected by the discontinued marketing of the products subject to those NDAs. 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 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23084 Filed 10-21-21; 8:45 am]
BILLING CODE 4164-01-P