Determination That GANITE (Gallium Nitrate) Injectable and Five Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 9225-9226 [2014-03458]

Download as PDF Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices Respondents to this collection of information are generic animal drug applicants. Based on data for the past 3 years, FDA estimates there are approximately 20 submissions annually and a total of 3.2 burden hours. Dated: February 10, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–03352 Filed 2–14–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–P–0948] Determination That STAVZOR (Valproic Acid) Delayed-Release Capsules, 125 Milligrams, 250 Milligrams, and 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined that STAVZOR (valproic acid) delayed-release capsules, 125 milligrams (mg), 250 mg, and 500 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for valproic acid, delayed-release capsules, 125 mg, 250 mg, and 500 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Na’Im R. Moses, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6223, Silver Spring, MD 20993–0002, 240– 402–3990. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products 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 tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 20:58 Feb 14, 2014 Jkt 232001 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 known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are 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). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. STAVZOR (valproic acid) delayedrelease capsules, 125 mg, 250 mg, and 500 mg, is the subject of NDA 22–152, held by Banner Pharmacaps Inc., and initially approved on July 29, 2008. STAVZOR is indicated for acute treatment of manic or mixed episodes associated with bipolar disorder (with or without psychotic features), monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures, adjunctive therapy in patients with multiple seizure types that include absence seizures, and prophylaxis of migraine headaches. In a letter dated June 25, 2013, Banner Pharmacaps Inc. notified FDA that STAVZOR (valproic acid) delayedrelease capsules, 125 mg, 250 mg, and 500 mg, was being discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Pharmaceutics International, Inc., submitted a citizen petition dated August 7, 2013 (Docket No. FDA–2013– P–0948), under 21 CFR 10.30, requesting that the Agency determine whether STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 9225 § 314.161 that STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of STAVZOR (valproic acid) delayedrelease capsules, 125 mg, 250 mg, and 500 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to STAVZOR (valproic acid) delayedrelease capsules, 125 mg, 250 mg, and 500 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: February 12, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–03455 Filed 2–14–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0161] Determination That GANITE (Gallium Nitrate) Injectable and Five Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined SUMMARY: E:\FR\FM\18FEN1.SGM 18FEN1 9226 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices 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: Amy Hopkins, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6207, Silver Spring, MD 20993–0002, 301– 796–5418. In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) (the 1984 amendments), which authorized the approval of duplicate SUPPLEMENTARY INFORMATION: 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 in this document are no longer being marketed. Application no. Drug Applicant NDA 019961 ........................................ GANITE (gallium nitrate) Injectable; Injection, 25 milligrams (mg)/milliliter (mL). SKELID (tiludronate disodium) Tablet; Oral, Equivalent to (EQ) 200 mg Base. EMEND (fosaprepitant dimeglumine) Powder; Intravenous, EQ 115 mg Base/Vial. GARAMYCIN (gentamicin sulfate ophthalmic solution) Solution; Drops, EQ 0.3% Base. JUVISYNC (simvastin; sitagliptin phosphate) Tablet; Oral, 10 mg, EQ 100 mg Base; 20 mg, EQ 100 mg Base; 40 mg, EQ 100 mg Base; 10 mg, EQ 50 mg Base; 20 mg, EQ 50 mg Base; 40 mg, EQ 50 mg Base. TRIMETHOPRIM (trimethoprim) Tablet; Oral, 200 mg. Chapter 7 Trustee of Genta Inc., 1628 John Kennedy Blvd., Philadelphia, PA 19103 Sanofi Aventis US LLC, 55 Corporate Dr., Bridgewater, NJ 08807. Merck and Co Inc., RY33 200, P.O. Box 2000, Rahway, NJ 07065. Schering Plough Corp., 2000 Galloping Hill Rd., Mail Stop K 6 1, Kenilworth, NJ 07033. Merck Sharp and Dohme Corp., 351 North Sumneytown Pike, UG 2CD 015, P.O. Box 1000, North Wales, PA 19454. NDA 020707 ........................................ NDA 022023 ........................................ NDA 050039 ........................................ NDA 202343 ........................................ tkelley on DSK3SPTVN1PROD with NOTICES ANDA 071259 ...................................... FDA has reviewed its records and, under § 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 VerDate Mar<15>2010 20:58 Feb 14, 2014 Jkt 232001 TEVA Pharmaceuticals USA Inc., 650 Cathill Rd., Sellersville, PA 18960–1512. 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: February 12, 2014. Leslie Kux, Assistant Commissioner for Policy. Requests for Feedback on Medical Device Submissions: The PreSubmission Program and Meetings With Food and Drug Administration Staff; Guidance for Industry and Food and Drug Administration Staff; Availability [FR Doc. 2014–03458 Filed 2–14–14; 8:45 am] BILLING CODE 4160–01–P PO 00000 Food and Drug Administration [Docket No. FDA–2012–D–0530] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Requests for Feedback on Medical Device Submissions: The PreSubmission Program and Meetings with SUMMARY: Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\18FEN1.SGM 18FEN1

Agencies

[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9225-9226]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03458]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0161]


Determination That GANITE (Gallium Nitrate) Injectable and Five 
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) has determined

[[Page 9226]]

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: Amy Hopkins, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6207, Silver Spring, MD 20993-0002, 301-
796-5418.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 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                Applicant
------------------------------------------------------------------------
NDA 019961..................  GANITE (gallium       Chapter 7 Trustee of
                               nitrate)              Genta Inc., 1628
                               Injectable;           John Kennedy Blvd.,
                               Injection, 25         Philadelphia, PA
                               milligrams (mg)/      19103
                               milliliter (mL).
NDA 020707..................  SKELID (tiludronate   Sanofi Aventis US
                               disodium) Tablet;     LLC, 55 Corporate
                               Oral, Equivalent to   Dr., Bridgewater,
                               (EQ) 200 mg Base.     NJ 08807.
NDA 022023..................  EMEND (fosaprepitant  Merck and Co Inc.,
                               dimeglumine)          RY33 200, P.O. Box
                               Powder;               2000, Rahway, NJ
                               Intravenous, EQ 115   07065.
                               mg Base/Vial.
NDA 050039..................  GARAMYCIN             Schering Plough
                               (gentamicin sulfate   Corp., 2000
                               ophthalmic            Galloping Hill Rd.,
                               solution) Solution;   Mail Stop K 6 1,
                               Drops, EQ 0.3% Base.  Kenilworth, NJ
                                                     07033.
NDA 202343..................  JUVISYNC (simvastin;  Merck Sharp and
                               sitagliptin           Dohme Corp., 351
                               phosphate) Tablet;    North Sumneytown
                               Oral, 10 mg, EQ 100   Pike, UG 2CD 015,
                               mg Base; 20 mg, EQ    P.O. Box 1000,
                               100 mg Base; 40 mg,   North Wales, PA
                               EQ 100 mg Base; 10    19454.
                               mg, EQ 50 mg Base;
                               20 mg, EQ 50 mg
                               Base; 40 mg, EQ 50
                               mg Base.
ANDA 071259.................  TRIMETHOPRIM          TEVA Pharmaceuticals
                               (trimethoprim)        USA Inc., 650
                               Tablet; Oral, 200     Cathill Rd.,
                               mg.                   Sellersville, PA
                                                     18960-1512.
------------------------------------------------------------------------

    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: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03458 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P

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