81 FR 19190 - Determination That PRONESTYL (Procainamide Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 64 (April 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 64 (April 4, 2016)
| Page Range | 19190-19190 | |
| FR Document | 2016-07610 |
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)] [Notices] [Page 19190] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-07610] [[Page 19190]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1076] Determination That PRONESTYL (Procainamide Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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. 6207, 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 in this document are no longer being marketed. -------------------------------------------------------------------------------------------------------------------------------------------------------- Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant -------------------------------------------------------------------------------------------------------------------------------------------------------- NDA 007335............. PRONESTYL.......................... Procainamide 100 milligrams (mg)/ Injectable; Injection Apothecon Hydrochloride. milliliter (mL); 500 Pharmaceuticals Pvt. mg/mL. Ltd. 250 mg; 375 mg; 500 Capsule; Oral........ mg. NDA 016020............. SYMMETREL.......................... Amantadine 100 mg............... Capsule; Oral........ Endo Pharmaceuticals Hydrochloride. Inc. NDA 018127............. OVCON-35........................... Ethinyl Estradiol; 0.035 mg; 0.4 mg..... Tablet; Oral-21...... Warner Chilcott LLC. Norethindrone. NDA 018309............. TOPICORT LP........................ Desoximetasone....... 0.05%................ Cream; Topical....... Taro Pharmaceutical Industries Ltd. NDA 021431............. CAMPRAL............................ Acamprosate Calcium.. 333 mg............... Delayed-release Forest Laboratories, Tablets; Oral. Inc. NDA 050195............. OXACILLIN SODIUM................... Oxacillin Sodium..... Equivalent to (EQ) Injectable; Injection Apothecon 250 mg base/vial; EQ Pharmaceuticals Pvt. 500 mg base/vial; EQ Ltd. 1 gram (g) base/ vial; EQ 2 g base/ vial; EQ 4 g base/ vial. ANDA 061334............ BACTOCILL.......................... Oxacillin Sodium..... EQ 500 mg base/vial; Injectable; Injection GlaxoSmithKline EQ 1 g base/vial; EQ 2 g base/vial; EQ 4 g base/vial; EQ 10 g base/vial. ANDA 075730............ THIOTEPA........................... Thiotepa............. 15 mg/vial; 30 mg/ Injectable; Injection Teva Parenteral vial. ANDA 077612............ SULFAMETHOXAZOLE AND TRIMETHOPRIM.. Sulfamethoxazole; 200 mg/5 mL; 40 mg/5 Suspension; Oral..... ANI Pharmaceuticals, Trimethoprim. mL. Inc. -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA has reviewed its records and, under Sec. 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document 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 in this document 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: March 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-07610 Filed 4-1-16; 8:45 am] BILLING CODE 4164-01-P
![19190 Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices
DEPARTMENT OF HEALTH AND and Research, Food and Drug which is generally known as the
HUMAN SERVICES Administration, 10903 New Hampshire ‘‘Orange Book.’’ Under FDA regulations,
Ave., Bldg. 51, Rm. 6207, Silver Spring, a drug is removed from the list if the
Food and Drug Administration MD 20993–0002, 301–796–8363, Agency withdraws or suspends
Stacy.Kane@fda.hhs.gov. approval of the drug’s NDA or ANDA
[Docket No. FDA–2016–N–1076]
SUPPLEMENTARY INFORMATION: In 1984, for reasons of safety or effectiveness, or
Determination That PRONESTYL Congress enacted the Drug Price if FDA determines that the listed drug
(Procainamide Hydrochloride) Competition and Patent Term was withdrawn from sale for reasons of
Injectable and Other Drug Products Restoration Act of 1984 (Pub. L. 98–417) safety or effectiveness (21 CFR 314.162).
Were Not Withdrawn From Sale for (the 1984 amendments), which Under § 314.161(a) (21 CFR
Reasons of Safety or Effectiveness authorized the approval of duplicate 314.161(a)), the Agency must determine
versions of drug products approved whether a listed drug was withdrawn
AGENCY: Food and Drug Administration, under an ANDA procedure. ANDA
HHS. from sale for reasons of safety or
applicants must, with certain
effectiveness: (1) Before an ANDA that
ACTION: Notice. exceptions, show that the drug for
refers to that listed drug may be
which they are seeking approval
SUMMARY: The Food and Drug approved, (2) whenever a listed drug is
contains the same active ingredient in
Administration (FDA or Agency) has voluntarily withdrawn from sale and
the same strength and dosage form as
determined that the drug products listed ANDAs that refer to the listed drug have
the ‘‘listed drug,’’ which is a version of
in this document were not withdrawn been approved, and (3) when a person
the drug that was previously approved.
from sale for reasons of safety or petitions for such a determination under
ANDA applicants do not have to repeat
effectiveness. This determination means 21 CFR 10.25(a) and 10.30. Section
the extensive clinical testing otherwise
that FDA will not begin procedures to 314.161(d) provides that if FDA
necessary to gain approval of a new
withdraw approval of abbreviated new determines that a listed drug was
drug application (NDA).
drug applications (ANDAs) that refer to The 1984 amendments include what withdrawn from sale for safety or
these drug products, and it will allow is now section 505(j)(7) of the Federal effectiveness reasons, the Agency will
FDA to continue to approve ANDAs that Food, Drug, and Cosmetic Act (21 U.S.C. initiate proceedings that could result in
refer to the products as long as they 355(j)(7)), which requires FDA to the withdrawal of approval of the
meet relevant legal and regulatory publish a list of all approved drugs. ANDAs that refer to the listed drug.
requirements. FDA publishes this list as part of the FDA has become aware that the drug
FOR FURTHER INFORMATION CONTACT: ‘‘Approved Drug Products With products listed in the table in this
Stacy Kane, Center for Drug Evaluation Therapeutic Equivalence Evaluations,’’ document are no longer being marketed.
Active
Application No. Drug name Strength(s) Dosage form/route Applicant
ingredient(s)
NDA 007335 ... PRONESTYL .................... Procainamide Hydro- 100 milligrams (mg)/milliliter (mL); 500 mg/ Injectable; Injection ... Apothecon Pharma-
chloride. mL. ceuticals Pvt. Ltd.
250 mg; 375 mg; 500 mg ............................. Capsule; Oral.
NDA 016020 ... SYMMETREL .................... Amantadine Hydro- 100 mg .......................................................... Capsule; Oral ............ Endo Pharma-
chloride. ceuticals Inc.
NDA 018127 ... OVCON–35 ....................... Ethinyl Estradiol; 0.035 mg; 0.4 mg ......................................... Tablet; Oral-21 .......... Warner Chilcott LLC.
Norethindrone.
NDA 018309 ... TOPICORT LP .................. Desoximetasone ....... 0.05% ............................................................ Cream; Topical .......... Taro Pharmaceutical
Industries Ltd.
NDA 021431 ... CAMPRAL ......................... Acamprosate Calcium 333 mg .......................................................... Delayed-release Tab- Forest Laboratories,
lets; Oral. Inc.
NDA 050195 ... OXACILLIN SODIUM ........ Oxacillin Sodium ....... Equivalent to (EQ) 250 mg base/vial; EQ Injectable; Injection ... Apothecon Pharma-
500 mg base/vial; EQ 1 gram (g) base/ ceuticals Pvt. Ltd.
vial; EQ 2 g base/vial; EQ 4 g base/vial.
ANDA 061334 BACTOCILL ...................... Oxacillin Sodium ....... EQ 500 mg base/vial; EQ 1 g base/vial; EQ Injectable; Injection ... GlaxoSmithKline
2 g base/vial; EQ 4 g base/vial; EQ 10 g
base/vial.
ANDA 075730 THIOTEPA ........................ Thiotepa .................... 15 mg/vial; 30 mg/vial ................................... Injectable; Injection ... Teva Parenteral
ANDA 077612 SULFAMETHOXAZOLE Sulfamethoxazole; 200 mg/5 mL; 40 mg/5 mL ........................... Suspension; Oral ...... ANI Pharmaceuticals,
AND TRIMETHOPRIM. Trimethoprim. Inc.
FDA has reviewed its records and, from marketing for reasons other than current standards, the Agency will
under § 314.161, has determined that safety or effectiveness. advise ANDA applicants to submit such
the drug products listed in this Approved ANDAs that refer to the labeling.
document were not withdrawn from NDAs and ANDAs listed in this Dated: March 29, 2016.
sale for reasons of safety or document are unaffected by the Leslie Kux,
effectiveness. Accordingly, the Agency discontinued marketing of the products
mstockstill on DSK4VPTVN1PROD with NOTICES
will continue to list the drug products Associate Commissioner for Policy.
subject to those NDAs and ANDAs.
[FR Doc. 2016–07610 Filed 4–1–16; 8:45 am]
listed in this document in the Additional ANDAs that refer to these
‘‘Discontinued Drug Product List’’ products may also be approved by the BILLING CODE 4164–01–P
section of the Orange Book. The Agency if they comply with relevant
‘‘Discontinued Drug Product List’’ legal and regulatory requirements. If
identifies, among other items, drug FDA determines that labeling for these
products that have been discontinued drug products should be revised to meet
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Document Created: 2016-04-02 03:53:46
Document Modified: 2016-04-02 03:53:46
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363, [email protected] | |
| FR Citation | 81 FR 19190 |
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