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Notice

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(Butabarbital Sodium) Oral Tablets, 15 Milligrams, 50 Milligrams, and 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 if they meet relevant legal and regulatory requirements.

Start Further Info

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.

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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of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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 § 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 nameActive ingredient(s)Strength(s)Dosage form/routeApplicant
NDA 000793BUTISOL SODIUMButabarbital Sodium15 mg; 50 mg; 100 mgTablet; OralMylan Specialty, L.P.
NDA 007392SECONAL SODIUMSecobarbital Sodium50 mg/Milliliter (mL)Injectable; InjectionEli Lilly and Co.
NDA 012665VELBANVinblastine Sulfate10 mg/VialInjectable; InjectionEli Lilly and Co.
NDA 017015PAVULONPancuronium Bromide1 mg/mL; 2 mg/mLInjectable; InjectionSchering-Plough Corp.
NDA 017919ORTHO-NOVUM 1/35-28Ethinyl Estradiol; Norethindrone0.035 mg;1 mgTablet; Oral-28Janssen Pharmaceuticals, Inc.
NDA 018554EULEXINFlutamide125 mgCapsule; OralSchering-Plough Corp.
NDA 019151RYTHMOLPropafenone Hydrochloride150 mg, 225 mg, 300 mgTablet; OralGlaxoSmithKline.
NDA 019579TERAZOL 7Terconazole0.4%Cream; VaginalJanssen Pharmaceuticals, Inc.
NDA 019599NAFTINNaftifine Hydrochloride1%Cream; TopicalSebela Ireland Limited.
NDA 019653ORTHO CYCLEN-28Ethinyl Estradiol; Norgestimate0.035 mg; 0.25 mgTablet; Oral-28Janssen Pharmaceuticals, Inc.
NDA 019716DIPROLENEBetamethasone DipropionateEQ 0.05% BaseLotion, Augmented; TopicalMerck Sharp & Dohme Corp.
NDA 019964TERAZOL 3Terconazole0.8%Cream; VaginalJanssen Pharmaceuticals, Inc.
NDA 020313MIACALCINCalcitonin Salmon200 International Units/SprayMetered Spray; NasalMylan Ireland Limited.
NDA 020388NAVELBINEVinorelbine TartrateEQ 10 mg Base/mLInjectable; InjectionPierre Fabre Medicament.
NDA 020413ZERITStavudine1 mg/mLFor Solution; OralBristol-Myers Squibb.
NDA 020741PRANDINRepaglinide0.5 mg; 1 mg; 2 mgTablet; OralGemini Laboratories, LLC.
NDA 020872CHILDREN'S ALLEGRA ALLERGYFexofenadine Hydrochloride30 mgTablet; OralSanofi-Aventis U.S., LLC.
NDA 021071AVANDIARosiglitazone MaleateEQ 8 mg BaseTablets; OralSB Pharmco Puerto Rico, Inc.
NDA 021235PROZAC WEEKLYFluoxetine HydrochlorideEQ 90 mg/BaseDelayed-Release Capsules; OralEli Lilly and Co.
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NDA 021909CHILDREN'S ALLEGRA HIVESFexofenadine Hydrochloride30 mgTablet, Orally Disintegrating; OralSanofi-Aventis U.S., LLC.
NDA 022246METOZOLV ODTMetoclopramide HydrochlorideEQ 5 mg BaseTablet, Orally Disintegrating; OralBausch Health US, LLC.
NDA 022291PROMACTAEltrombopag OlamineEQ 100 mg AcidTablet; OralNovartis.
NDA 022362WELCHOLColesevelam Hydrochloride1.875 g/PacketFor Suspension; OralDaiichi Sankyo.
NDA 022396DYLOJECTDiclofenac Sodium37.5 mg/mL (37.5 mg/mL)Solution; IntravenousJavelin Pharmaceuticals, Inc.
NDA 050368ILOTYCINErythromycin0.5%Ointment; OphthalmicEli Lilly and Co.
NDA 050587PRIMAXINCilastatin Sodium; ImipenemEQ 250 mg Base/Vial; 250 mg/VialPowder; IntravenousMerck & Co., Inc.
NDA 201373CHILDREN'S ALLEGRA HIVESFexofenadine Hydrochloride30 mg/5 mLSuspension; OralSanofi-Aventis U.S., LLC.
NDA 208411NARCANNaloxone Hydrochloride2 mg/SpraySpray, Metered; NasalAdapt Pharma.

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 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.

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Dated: October 16, 2020.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2020-23300 Filed 10-20-20; 8:45 am]

BILLING CODE 4164-01-P