80 FR 66911 - Determination That TENSILON and TENSILON Preservative Free (Edrophonium Chloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 80, Issue 210 (October 30, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 210 (October 30, 2015)
| Page Range | 66911-66912 | |
| FR Document | 2015-27740 |
[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)] [Notices] [Pages 66911-66912] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27740] [[Page 66911]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3894] Determination That TENSILON and TENSILON Preservative Free (Edrophonium Chloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 Applicant ------------------------------------------------------------------------ NDA 007959................ TENSILON and TENSILON IGI Laboratories, Preservative Free Inc., 105 Lincoln (edrophonium Ave., Buena, NJ chloride) 08310. Injectable; Intravenous, 10 milligrams/ milliliter (mg/mL). NDA 013416................ NORGESIC and NORGESIC Medicis FORTE (aspirin, Pharmaceuticals, caffeine, Division of Valeant orphenadrine Pharmaceuticals citrate) Tablet; North America, LLC, Oral,385 mg/30 mg/25 400 Somerset mg; 770 mg/60 mg/50 Corporate Blvd., mg. Bridgewater, NJ 08807. NDA 018225................ BUMEX (bumetanide) Validus Tablet; Oral, 0.5 Pharmaceuticals, mg; 1 mg; 2 mg. LLC, 119 Cherry Hill Rd., Suite 310, Parsippany, NJ 07054. NDA 018343................ CAPOTEN (captopril) Par Pharmaceutical Tablet; Oral, 12.5 Inc., 1 Ram Ridge mg; 25 mg; 50 mg; Rd., Chestnut Ridge, 100 mg. NY 10977. NDA 019322................ TEMOVATE (clobetasol Fougera propionate) Cream; Pharmaceuticals Topical, 0.05%. Inc., 60 Baylis Rd., P.O. Box 2006, Melville, NY 11747. NDA 020337................ TEMOVATE (clobetasol Do. propionate) Gel; Topical, 0.05%. NDA 020340................ TEMOVATE E Do. (clobetasol propionate) Cream; Topical, 0.05%. NDA 020638................ VISTIDE (cidofovir) Gilead Sciences, Injectable; Inc., 333 Lakeside Intravenous, 75 mg Dr., Foster City, CA base/mL. 94404. NDA 021700................ AVANDARYL SmithKline Beecham (glimepiride, (Cork) Ltd., rosiglitazone Ireland, 2301 maleate) Tablet; Renaissance Blvd., Oral, 1 mg/4 mg; 2 Mail Code RN 0420, mg/4 mg; 4 mg/4 mg; King of Prussia, PA 2 mg/8 mg; 4 mg/8 mg. 19406. NDA 022411................ OLEPTRO (trazodone Angelini Pharma Inc., HCl); Extended- 8322 Helgerman Ct., Release Tablet; Gaithersburg, MD Oral, 150 mg; 300 mg. 20877. NDA 050461................ ANCEF (cefazolin GlaxoSmithKline, 1 sodium) Injectable; Franklin Plaza, P.O. Intravenous, 1 gram Box 7929, (g)/vial; 10 g/vial. Philadelphia, PA 19101. NDA 050495................ AMIKIN (amikacin Apothecon, Inc., P.O. sulfate) Injectable; Box 4500, Princeton, Intravenous, EQ 50 NJ 08543. mg base/mL; 250 mg base/mL. ANDA 064169............... Cefazolin Sodium Fresenius Kabi USA, Injectable; LLC, 3 Corporate Intravenous, 500 mg Dr., Lake Zurich, IL base/vial; 1 g base/ 60047. vial. ------------------------------------------------------------------------ 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 [[Page 66912]] 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 26, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27740 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices 66911
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
[Docket No. FDA–2015–N–3894] Stacy.Kane@fda.hhs.gov. approval of the drug’s NDA or ANDA
SUPPLEMENTARY INFORMATION: In 1984, for reasons of safety or effectiveness, or
Determination That TENSILON and Congress enacted the Drug Price if FDA determines that the listed drug
TENSILON Preservative Free Competition and Patent Term was withdrawn from sale for reasons of
(Edrophonium Chloride) Injectable and Restoration Act of 1984 (Pub. L. 98–417) safety or effectiveness (21 CFR 314.162).
Other Drug Products Were Not (the 1984 amendments), which
Withdrawn From Sale for Reasons of Under § 314.161(a) (21 CFR
authorized the approval of duplicate 314.161(a)), the Agency must determine
Safety or Effectiveness versions of drug products approved whether a listed drug was withdrawn
AGENCY: Food and Drug Administration, under an ANDA procedure. ANDA from sale for reasons of safety or
HHS. 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 approved, (2) whenever a listed drug is
SUMMARY: The Food and Drug 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 ANDA applicants do not have to repeat petitions for such a determination under
effectiveness. This determination means the extensive clinical testing otherwise 21 CFR 10.25(a) and 10.30. Section
that FDA will not begin procedures to necessary to gain approval of a new 314.161(d) provides that if FDA
withdraw approval of abbreviated new drug application (NDA). determines that a listed drug was
drug applications (ANDAs) that refer to withdrawn from sale for safety or
The 1984 amendments include what
these drug products, and it will allow effectiveness reasons, the Agency will
is now section 505(j)(7) of the Federal
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.
Application No. Drug Applicant
NDA 007959 ..... TENSILON and TENSILON Preservative Free (edrophonium IGI Laboratories, Inc., 105 Lincoln Ave., Buena, NJ 08310.
chloride) Injectable; Intravenous, 10 milligrams/milliliter
(mg/mL).
NDA 013416 ..... NORGESIC and NORGESIC FORTE (aspirin, caffeine, Medicis Pharmaceuticals, Division of Valeant Pharma-
orphenadrine citrate) Tablet; Oral,385 mg/30 mg/25 mg; ceuticals North America, LLC, 400 Somerset Corporate
770 mg/60 mg/50 mg. Blvd., Bridgewater, NJ 08807.
NDA 018225 ..... BUMEX (bumetanide) Tablet; Oral, 0.5 mg; 1 mg; 2 mg ........ Validus Pharmaceuticals, LLC, 119 Cherry Hill Rd., Suite
310, Parsippany, NJ 07054.
NDA 018343 ..... CAPOTEN (captopril) Tablet; Oral, 12.5 mg; 25 mg; 50 mg; Par Pharmaceutical Inc., 1 Ram Ridge Rd., Chestnut Ridge,
100 mg. NY 10977.
NDA 019322 ..... TEMOVATE (clobetasol propionate) Cream; Topical, 0.05% .. Fougera Pharmaceuticals Inc., 60 Baylis Rd., P.O. Box 2006,
Melville, NY 11747.
NDA 020337 ..... TEMOVATE (clobetasol propionate) Gel; Topical, 0.05% ....... Do.
NDA 020340 ..... TEMOVATE E (clobetasol propionate) Cream; Topical, 0.05% Do.
NDA 020638 ..... VISTIDE (cidofovir) Injectable; Intravenous, 75 mg base/mL .. Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA
94404.
NDA 021700 ..... AVANDARYL (glimepiride, rosiglitazone maleate) Tablet; SmithKline Beecham (Cork) Ltd., Ireland, 2301 Renaissance
Oral, 1 mg/4 mg; 2 mg/4 mg; 4 mg/4 mg; 2 mg/8 mg; 4 Blvd., Mail Code RN 0420, King of Prussia, PA 19406.
mg/8 mg.
NDA 022411 ..... OLEPTRO (trazodone HCl); Extended-Release Tablet; Oral, Angelini Pharma Inc., 8322 Helgerman Ct., Gaithersburg, MD
150 mg; 300 mg. 20877.
NDA 050461 ..... ANCEF (cefazolin sodium) Injectable; Intravenous, 1 gram GlaxoSmithKline, 1 Franklin Plaza, P.O. Box 7929, Philadel-
(g)/vial; 10 g/vial. phia, PA 19101.
NDA 050495 ..... AMIKIN (amikacin sulfate) Injectable; Intravenous, EQ 50 mg Apothecon, Inc., P.O. Box 4500, Princeton, NJ 08543.
base/mL; 250 mg base/mL.
ANDA 064169 ... Cefazolin Sodium Injectable; Intravenous, 500 mg base/vial; Fresenius Kabi USA, LLC, 3 Corporate Dr., Lake Zurich, IL
1 g base/vial. 60047.
tkelley on DSK3SPTVN1PROD with NOTICES
FDA has reviewed its records and, will continue to list the drug products products that have been discontinued
under § 314.161, has determined that listed in this document in the from marketing for reasons other than
the drug products listed in this ‘‘Discontinued Drug Product List’’ safety or effectiveness.
document were not withdrawn from section of the Orange Book. The Approved ANDAs that refer to the
sale for reasons of safety or ‘‘Discontinued Drug Product List’’ NDAs and ANDAs listed in this
effectiveness. Accordingly, the Agency identifies, among other items, drug document are unaffected by the
VerDate Sep<11>2014 17:37 Oct 29, 2015 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/80_FR_67121/page/1.svg)
![66912 Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices
discontinued marketing of the products has assigned OMB control number Dated: October 26, 2015.
subject to those NDAs and ANDAs. 0910–0803. The approval expires on Leslie Kux,
Additional ANDAs that refer to these September 30, 2018. A copy of the Associate Commissioner for Policy.
products may also be approved by the supporting statement for this [FR Doc. 2015–27742 Filed 10–29–15; 8:45 am]
Agency if they comply with relevant information collection is available on BILLING CODE 4164–01–P
legal and regulatory requirements. If the Internet at http://www.reginfo.gov/
FDA determines that labeling for these public/do/PRAMain.
drug products should be revised to meet Dated: October 26, 2015. DEPARTMENT OF HEALTH AND
current standards, the Agency will Leslie Kux, HUMAN SERVICES
advise ANDA applicants to submit such
Associate Commissioner for Policy.
labeling. Performance Review Board Members
[FR Doc. 2015–27743 Filed 10–29–15; 8:45 am]
Dated: October 26, 2015. BILLING CODE 4164–01–P Title 5, U.S.C. Section 4314(c)(4) of
Leslie Kux, the Civil Service Reform Act of 1978,
Associate Commissioner for Policy. Public Law 95–454, requires that the
[FR Doc. 2015–27740 Filed 10–29–15; 8:45 am] DEPARTMENT OF HEALTH AND appointment of Performance Review
BILLING CODE 4164–01–P HUMAN SERVICES Board Members be published in the
Federal Register.
Food and Drug Administration The following persons may be named
DEPARTMENT OF HEALTH AND [Docket No. FDA–2014–N–1491] to serve on the Performance Review
HUMAN SERVICES Boards or Panels, which oversee the
Agency Information Collection evaluation of performance appraisals of
Food and Drug Administration Activities; Announcement of Office of Senior Executive Service members of
[Docket No. FDA–2014–N–1794] Management and Budget Approval; the Department of Health and Human
Survey of Pharmacists and Patients; Services.
Agency Information Collection Variations in the Physical
Activities; Announcement of Office of Characteristics of Generic Drug Pills Employee last name Employee first name
Management and Budget Approval; and Patient Perceptions Agrawal ..................... Shantanu
Impact of Ad Exposure Frequency on Atkinson .................... Leslie
AGENCY: Food and Drug Administration,
Perception and Mental Processing of Boulanger .................. Jennifer
HHS.
Risks and Benefit Information in Bowers ...................... Tonya
Direct-to-Consumer Prescription Drug ACTION: Notice. Burton ........................ Adriane
Ads SUMMARY: The Food and Drug Cannistra ................... Jennifer
Cantwell .................... Kathleen
AGENCY: Food and Drug Administration, Administration (FDA) is announcing Carter ........................ Cathy
HHS. that a collection of information entitled Cavanaugh ................ Sean
ACTION: Notice. ‘‘Survey of Pharmacists and Patients; Cheatham .................. Tina
Variations in the Physical Cheever ..................... Laura
SUMMARY: The Food and Drug Characteristics of Generic Drug Pills and Conway ..................... Patrick
Administration (FDA) is announcing Patient Perceptions’’ has been approved Counihan ................... Keven
that a collection of information entitled by the Office of Management and Dammons .................. Cheryl
‘‘Impact of Ad Exposure Frequency on Budget (OMB) under the Paperwork Devoss ...................... Elizabeth
Espinosa ................... Diana
Perception and Mental Processing of Reduction Act of 1995. Etziner ....................... Michael
Risks and Benefit Information in Direct- FOR FURTHER INFORMATION CONTACT: FDA Garcia ........................ Alexandra
to-Consumer Prescription Drug Ads’’ PRA Staff, Office of Operations, Food Garner ....................... Jacqueline
has been approved by the Office of and Drug Administration, 8455 Goldhaber ................. Ben
Management and Budget (OMB) under Colesville Rd., COLE–14526, Silver Goodman .................. Richard
the Paperwork Reduction Act of 1995. Spring, MD 20993–0002, PRAStaff@ Hamilton .................... Thomas
FOR FURTHER INFORMATION CONTACT: FDA fda.hhs.gov. Hammarlund .............. John
Handley ..................... Elisabeth
PRA Staff, Office of Operations, Food SUPPLEMENTARY INFORMATION: On May Hartstein .................... Marc
and Drug Administration, 8455 28, 2015, the Agency submitted a Haseltine ................... Amy
Colesville Rd., COLE–14526, Silver proposed collection of information Hattery ....................... Debbra
Spring, MD 20993–0002, PRAStaff@ entitled ‘‘Survey of Pharmacists and Heffler ........................ Stephen
fda.hhs.gov. Patients; Variations in the Physical Hill ............................. Timothy
Jackson ..................... Karen
SUPPLEMENTARY INFORMATION: On June Characteristics of Generic Drug Pills and
Kane .......................... Daniel
29, 2015, the Agency submitted a Patient Perceptions’’ to OMB for review Kavanagh .................. Laura
proposed collection of information and clearance under 44 U.S.C. 3507. An Kerr ........................... James
entitled ‘‘Impact of Ad Exposure Agency may not conduct or sponsor, Killoran ...................... Beth
Frequency on Perception and Mental and a person is not required to respond Kramer ...................... Martin
Processing of Risks and Benefit to, a collection of information unless it Kretschmaier ............. Michon
Information in Direct-to-Consumer displays a currently valid OMB control Lewis ......................... Lisa
Prescription Drug Ads’’ to OMB for number. OMB has now approved the Lodes ........................ Lori
Lu .............................. Michael
tkelley on DSK3SPTVN1PROD with NOTICES
review and clearance under 44 U.S.C. information collection and has assigned
Macrae ...................... James
3507. An Agency may not conduct or OMB control number 0910–0801. The
Malcomson ................ Dennis
sponsor, and a person is not required to approval expires on September 30, Mills ........................... George
respond to, a collection of information 2018. A copy of the supporting Montilla ...................... Maria
unless it displays a currently valid OMB statement for this information collection Moody-Williams ......... Jean
control number. OMB has now is available on the Internet at http:// Morris ........................ Thomas
approved the information collection and www.reginfo.gov/public/do/PRAMain. Murray ....................... Renard
VerDate Sep<11>2014 17:37 Oct 29, 2015 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/80_FR_67121/page/2.svg)
Document Created: 2015-12-14 15:29:26
Document Modified: 2015-12-14 15:29:26
| 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 | 80 FR 66911 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR