[Federal Register Volume 85, Number 204 (Wednesday, October 21, 2020)]
[Notices]
[Pages 66994-66995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23300]
[[Page 66994]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2032]
Determination That BUTISOL SODIUM (Butabarbital Sodium) Oral
Tablets, 15 Milligrams, 50 Milligrams, and 100 Milligrams, 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Drug Products Were Not Withdrawn From Sale for Reasons of Safety or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withdrawn from sale for reasons of safety or effectiveness.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 if 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 000793............. BUTISOL SODIUM.. Butabarbital 15 mg; 50 mg; Tablet; Oral.... Mylan
Sodium. 100 mg. Specialty,
L.P.
NDA 007392............. SECONAL SODIUM.. Secobarbital 50 mg/Milliliter Injectable; Eli Lilly and
Sodium. (mL). Injection. Co.
NDA 012665............. VELBAN.......... Vinblastine 10 mg/Vial...... Injectable; Eli Lilly and
Sulfate. Injection. Co.
NDA 017015............. PAVULON......... Pancuronium 1 mg/mL; 2 mg/mL Injectable; Schering-Plough
Bromide. Injection. Corp.
NDA 017919............. ORTHO-NOVUM 1/35- Ethinyl 0.035 mg;1 mg... Tablet; Oral-28. Janssen
28. Estradiol; Pharmaceutical
Norethindrone. s, Inc.
NDA 018554............. EULEXIN......... Flutamide....... 125 mg.......... Capsule; Oral... Schering-Plough
Corp.
NDA 019151............. RYTHMOL......... Propafenone 150 mg, 225 mg, Tablet; Oral.... GlaxoSmithKline
Hydrochloride. 300 mg. .
NDA 019579............. TERAZOL 7....... Terconazole..... 0.4%............ Cream; Vaginal.. Janssen
Pharmaceutical
s, Inc.
NDA 019599............. NAFTIN.......... Naftifine 1%.............. Cream; Topical.. Sebela Ireland
Hydrochloride. Limited.
NDA 019653............. ORTHO CYCLEN-28. Ethinyl 0.035 mg; 0.25 Tablet; Oral-28. Janssen
Estradiol; mg. Pharmaceutical
Norgestimate. s, Inc.
NDA 019716............. DIPROLENE....... Betamethasone EQ 0.05% Base... Lotion, Merck Sharp &
Dipropionate. Augmented; Dohme Corp.
Topical.
NDA 019964............. TERAZOL 3....... Terconazole..... 0.8%............ Cream; Vaginal.. Janssen
Pharmaceutical
s, Inc.
NDA 020313............. MIACALCIN....... Calcitonin 200 Metered Spray; Mylan Ireland
Salmon. International Nasal. Limited.
Units/Spray.
NDA 020388............. NAVELBINE....... Vinorelbine EQ 10 mg Base/mL Injectable; Pierre Fabre
Tartrate. Injection. Medicament.
NDA 020413............. ZERIT........... Stavudine....... 1 mg/mL......... For Solution; Bristol-Myers
Oral. Squibb.
NDA 020741............. PRANDIN......... Repaglinide..... 0.5 mg; 1 mg; 2 Tablet; Oral.... Gemini
mg. Laboratories,
LLC.
NDA 020872............. CHILDREN'S Fexofenadine 30 mg........... Tablet; Oral.... Sanofi-Aventis
ALLEGRA ALLERGY. Hydrochloride. U.S., LLC.
NDA 021071............. AVANDIA......... Rosiglitazone EQ 8 mg Base.... Tablets; Oral... SB Pharmco
Maleate. Puerto Rico,
Inc.
NDA 021235............. PROZAC WEEKLY... Fluoxetine EQ 90 mg/Base... Delayed-Release Eli Lilly and
Hydrochloride. Capsules; Oral. Co.
[[Page 66995]]
NDA 021909............. CHILDREN'S Fexofenadine 30 mg........... Tablet, Orally Sanofi-Aventis
ALLEGRA HIVES. Hydrochloride. Disintegrating; U.S., LLC.
Oral.
NDA 022246............. METOZOLV ODT.... Metoclopramide EQ 5 mg Base.... Tablet, Orally Bausch Health
Hydrochloride. Disintegrating; US, LLC.
Oral.
NDA 022291............. PROMACTA........ Eltrombopag EQ 100 mg Acid.. Tablet; Oral.... Novartis.
Olamine.
NDA 022362............. WELCHOL......... Colesevelam 1.875 g/Packet.. For Suspension; Daiichi Sankyo.
Hydrochloride. Oral.
NDA 022396............. DYLOJECT........ Diclofenac 37.5 mg/mL (37.5 Solution; Javelin
Sodium. mg/mL). Intravenous. Pharmaceutical
s, Inc.
NDA 050368............. ILOTYCIN........ Erythromycin.... 0.5%............ Ointment; Eli Lilly and
Ophthalmic. Co.
NDA 050587............. PRIMAXIN........ Cilastatin EQ 250 mg Base/ Powder; Merck & Co.,
Sodium; Vial; 250 mg/ Intravenous. Inc.
Imipenem. Vial.
NDA 201373............. CHILDREN'S Fexofenadine 30 mg/5 mL...... Suspension; Oral Sanofi-Aventis
ALLEGRA HIVES. Hydrochloride. U.S., LLC.
NDA 208411............. NARCAN.......... Naloxone 2 mg/Spray...... Spray, Metered; Adapt Pharma.
Hydrochloride. Nasal.
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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 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: October 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23300 Filed 10-20-20; 8:45 am]
BILLING CODE 4164-01-P