Determination That KENALOG (Triamcinolone Acetonide) Ointment, 0.025% and 0.1%, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
| Published date | 01 October 2019 |
| Citation | 84 FR 52113 |
| Record Number | 2019-21201 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 84 Issue 190 (Tuesday, October 1, 2019)
[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52113-52114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21201]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4329]
Determination That KENALOG (Triamcinolone Acetonide) Ointment,
0.025% and 0.1%, and Other Drug Products Were Not Withdrawn From Sale
for Reasons of Safety or Effectiveness
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withdrawn from sale for reasons of safety or effectiveness.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,
[email protected].
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 011600................ KENALOG......................... Triamcinolone 0.025%; 0.1%......... Ointment; Topical.... Mylan
Acetonide. Pharmaceuticals,
Inc.
NDA 012827................ ROBINUL......................... Glycopyrrolate....... 1 milligram (mg)..... Tablet; Oral......... Casper Pharma LLC.
ROBINUL FORTE................... Glycopyrrolate....... 2 mg................. Tablet; Oral.........
NDA 018029................ RITALIN-SR...................... Methylphenidate 20 mg................ Extended-Release Novartis
Hydrochloride. Tablet; Oral. Pharmaceuticals,
Corp.
NDA 018164................ ANAPROX......................... Naproxen Sodium...... Equivalent to (EQ) Tablet; Oral......... ATNAHS Pharma U.S.,
250 mg Base. Ltd.
NDA 018405................ AYGESTIN........................ Norethindrone Acetate 5 mg................. Tablet; Oral......... Teva Branded
Pharmaceutical
Products R&D, Inc.
NDA 018452................ SEPTRA.......................... Sulfamethoxazole; 16 mg/milliliter Injectable; Injection Monarch
Trimethoprim. (mL); 80 mg/mL. Pharmaceuticals,
Inc.
NDA 018703................ ZANTAC 150...................... Ranitidine EQ 150 mg Base....... Tablet; Oral......... GlaxoSmithKline.
ZANTAC 300...................... Hydrochloride. EQ 300 mg Base....... Tablet; Oral.........
Ranitidine
Hydrochloride.
NDA 019111................ TUSSIONEX PENNKINETIC........... Chlorpheniramine EQ 8 mg Chlorphenir- Extended-Release UCB, Inc.
Polistirex; amine Maleate/5 mL; Suspension; Oral.
Hydrocodone EQ 10 mg Hydrocodone
Polistirex. Bitartrate/5 mL.
NDA 019507................ KERLONE......................... Betaxolol 10 mg; 20 mg......... Tablets; Oral........ Sanofi-Aventis U.S.
Hydrochloride. LLC.
NDA 019537................ CIPRO........................... Ciprofloxacin EQ 100 mg Base; EQ Tablet; Oral......... Bayer Healthcare
Hydrochloride. 750 mg Base. Pharmaceuticals,
Inc.
NDA 019937................ ADENOCARD....................... Adenosine............ 3 mg/mL.............. Injectable; Injection Astellas Pharma U.S.,
Inc.
NDA 020415................ REMERON......................... Mirtazapine.......... 45 mg................ Tablet; Oral......... Organon USA, Inc.
NDA 020528................ MAVIK........................... Trandolapril......... 1 mg; 2 mg; 4 mg..... Tablet; Oral......... AbbVie, Inc.
NDA 020864................ MAXALT.......................... Rizatriptan Benzoate. EQ 5 mg Base......... Tablet; Oral......... Merck Sharp & Dohme
Corp.
NDA 020865................ MAXALT-MLT...................... Rizatriptan Benzoate. EQ 5 mg Base......... Orally Disintegrating Do.
Tablet; Oral.
NDA 020945................ NORVIR.......................... Ritonavir............ 100 mg............... Capsule; Oral........ AbbVie, Inc.
NDA 021131................ ZYVOX........................... Linezolid............ 400 mg/200 mL (2 mg/ Injectable; Injection Pharmacia & Upjohn
mL). Co.
[[Page 52114]]
NDA 021381................ XYLOCAINE DENTAL WITH Epinephrine; 0.01 mg/mL/2%; 0.02 Injectable; Injection DENTSPLY
EPINEPHRINE. Lidocaine mg/mL/2%. Pharmaceutical, Inc.
Hydrochloride.
NDA 021511................ COPEGUS......................... Ribavirin............ 200 mg; 400 mg....... Tablet; Oral......... Hoffmann La-Roche,
Inc.
NDA 022325................ NEXTERONE....................... Amiodarone 50 mg/mL............. Injectable; Injection Baxter Healthcare,
Hydrochloride. Corp.
NDA 050605................ CEFTIN.......................... Cefuroxime Axetil.... EQ 125 mg Base; EQ Tablet; Oral......... GlaxoSmithKline.
250 mg Base; EQ 500
mg Base.
NDA 050730................ ZITHROMAX....................... Azithromycin......... EQ 600 mg Base....... Tablet; Oral......... Pfizer, Inc.
NDA 050746................ BACTROBAN....................... Mupirocin Calcium.... EQ 2% Base........... Cream; Topical....... GlaxoSmithKline.
NDA 205103................ YOSPRALA........................ Aspirin; Omeprazole.. 81 mg/40 mg; 325 mg/ Delayed-Release Genus Lifesciences,
40 mg. Tablet; Oral. Inc.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
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 and ANDAs listed are
unaffected by the discontinued marketing of the products subject to
those NDAs and ANDAs. 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: September 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21201 Filed 9-30-19; 8:45 am]
BILLING CODE 4164-01-P
