[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Notices]
[Pages 15682-15683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06059]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0279]
Determination That Folic Acid, Oral Tablets, 1 Milligram, and
Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety
or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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withdrawn from sale for reasons of safety or effectiveness.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.
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Active Dosage form/
Application No. Drug name ingredient(s) Strength(s) route Applicant
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NDA 006135.......... Folic Acid....... Folic Acid....... 1 milligram (mg) Tablet; Oral.... Eli Lilly & Co.
NDA 016131.......... CLOMID........... Clomiphene 50 mg........... Tablet; Oral.... Sanofi-Aventis
Citrate. U.S. LLC.
NDA 016419.......... Propranolol Propanolol 1 mg/milliliter Injectable; Baxter
Hydrochloride. Hydrochloride. (mL). Injection. Healthcare
Corp.
NDA 017473.......... ORAP............. Pimozide......... 1 mg; 2 mg...... Tablet; Oral.... Teva Pharms.,
USA, Inc.
NDA 019916.......... Morphine Sulfate. Morphine Sulfate. 1 mg/mL; 5 mg/mL Injectable; ICU Medical,
Injection. Inc.
NDA 019967.......... ULTRAVATE........ Halobetasol 0.05%........... Cream; Topical.. Sun
Propionate. Pharmaceutical
Industries,
Inc.
NDA 020647.......... ELDEPRYL......... Selegiline 5 mg............ Capsule; Oral... Somerset
Hydrochloride. Pharms., Inc.
NDA 020925.......... TAVIST-1......... Clemastine 1.34 mg......... Tablet; Oral.... GlaxoSmithKline
Fumarate. Consumer
Healthcare.
[[Page 15683]]
NDA 021015.......... ANDROGEL......... Testosterone..... 12.5 mg/1.25 g Gel, Metered; AbbVie Inc.
Actuation. Transdermal.
NDA 021204.......... STARLIX.......... Nateglinide...... 60 mg; 120 mg... Tablets; Oral... Novartis
Pharms., Corp.
NDA 021217.......... EXALGO........... Hydromorphone 8 mg; 12 mg; 16 Tablet, Extended- Specgx, LLC.
Hydrochloride. mg; 32 mg. Release; Oral.
NDA 021365.......... LEXAPRO.......... Escitalopram Equal to (EQ) 5 Solution; Oral.. Allergan Sales,
Oxalate. mg Base/5 mL. LLC.
NDA 021490.......... FEMCON FE........ Ethinyl 0.035 mg; 0.4 mg Tablet, Allergan
Estradiol; Chewable; Oral. Pharms.,
Norethindrone. International,
Ltd.
NDA 021860.......... SARAFEM.......... Fluoxetine EQ 15 mg Base... Tablet; Oral.... Allergan Pharms.
Hydrochloride. International,
Ltd.
NDA 021870.......... Fludeoxyglucose F- Fludeoxyglucose F- 20-200 Injectable; Feinstein
18. 18. Millicurie/mL. Intravenous. Institute
Medical
Research.
NDA 022442.......... REZIRA........... Hydrocodone 5 mg/5 mL; 60 mg/ Solution; Oral.. Persion Pharms.,
Bitartrate; 5 mL. LLC.
Pseudoephedrine
Hydrochloride.
NDA 050757.......... PREVPAC.......... Amoxicillin; 500 mg; 500 mg; Capsule, Tablet, Takeda Pharms.
Clarithromycin; 30 mg. Capsule; Oral. USA, Inc.
Lansoprazole.
NDA 203195.......... SUPRAX........... Cefixime......... 400 mg.......... Capsule; Oral... Lupin, Ltd.
NDA 207931.......... TECHNIVIE........ Ombitasvir; 12.5 mg; 75 mg; Tablet; Oral.... AbbVie Inc.
Paritaprevir; 50 mg.
Ritonavir.
NDA 208624.......... VIEKIRA XR....... Dasabuvir Sodium; EQ 200 mg Base; Tablet, Extended AbbVie Inc.
Ombitasvir; 8.33 mg; 50 mg; Release; Oral.
Paritaprevir; 33.33 mg.
Ritonavir.
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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 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: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06059 Filed 3-23-21; 8:45 am]
BILLING CODE 4164-01-P