Determination That TESSALON (Benzonatate) Capsules and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 42828-42829 [2015-17730]

Download as PDF 42828 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices Dated: July 15, 2015. Leslie Kux, Associate Commissioner for Policy. meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2015–17729 Filed 7–17–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–2412] Determination That TESSALON (Benzonatate) Capsules and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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 The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 SUMMARY: 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. 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 sponsors 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. ANDAs 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. (As requested by the applicant, FDA withdrew approval of NDA 050448 for GRIFULVIN (griseofulvin) Oral Suspension in the Federal Register of August 16, 2001 (66 FR 43017)). Application No. Drug Applicant NDA 011210 ...... NDA 012093 ...... TESSALON (benzonatate) Capsule; Oral 200 milligrams (mg) ISORDIL (isosorbide dinitrate) Tablet; Oral 10 mg, 20 mg, 30 mg. ACLOVATE (alclometasone dipropionate) Ointment; Topical 0.05%. ACLOVATE (alclometasone dipropionate) Cream; Topical 0.05%. SARAFEM (fluoxetine hydrochloride (HCl)) Capsule; Oral Equivalent to (EQ) 10 mg Base, EQ 20 mg Base. VASOCIDIN (prednisolone sodium phosphate; sulfacetamide sodium), Solution/Drops; Ophthalmic, EQ 0.23% phosphate; 10%. PRAVACHOL (pravastatin sodium) Tablet; Oral 10 mg .......... Pfizer Inc., 1 Giralda Farms, Madison, NJ 07940. Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. Fougera Pharmaceuticals Inc., 60 Baylis Rd., P.O. Box 2006, Melville, NY 11747. Do. NDA 018702 ...... NDA 018707 ...... NDA 018936 ...... NDA 018988 ...... NDA 019898 ...... NDA 020092 ...... NDA 021551 ...... NDA 021871 ...... mstockstill on DSK4VPTVN1PROD with NOTICES NDA 050448 ...... NDA 050719 ...... ANDA 040454 .... ANDA 062483 .... VerDate Sep<11>2014 DILACOR XR (diltiazem HCl) Capsule, Extended-Release; Oral 120 mg, 180 mg, 240 mg. HALFLYTELY (polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride) For Solution and bisacodyl Delayed-Release Tablets); Oral 210 grams (g); 0.74 g; 2.86 g; 5.6 g; 5 mg. LOESTRIN 24 FE (ethinyl estradiol; norethindrone acetate) Tablet; Oral 0.02 mg; 1 mg. GRIFULVIN V (griseofulvin, microcrystalline) Suspension; Oral 125 mg/5 milliliters (mL). HELIDAC (bismuth subsalicylate; metronidazole; tetracycline HCl) Tablet, Chewable, Tablet, Capsule; Oral 262.4 mg; 250 mg, 500 mg. PROMETHAZINE HYDROCHLORIDE (promethazine HCl) Injectable; Injection 25 mg/mL, 50 mg/mL. GRIFULVIN V (griseofulvin, microsize) Suspension; Oral 125 mg/5 mL. 16:30 Jul 17, 2015 Jkt 235001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Eli Lilly and Co., Lilly Corp. Ctr., Indianapolis, IN 46285. Novartis Pharmaceuticals Corp., 105 Eisenhower Pky., 280 Corporate Center, Roseland, NJ 07068. Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543–4000. Actavis Laboratories UT, Inc., 577 Chipeta Way, Salt Lake City, UT 84108. Braintree Laboratories, Inc., 60 Columbia St., P.O. Box 850929, Braintree, MA 02185. Warner Chilcott Co. LLC, Union Street Rd. 195 KM 1.1., Fajardo, Puerto Rico 00738. Johnson & Johnson Consumer Products Co., 199 Grandview Rd., Skillman, NJ 08558. Prometheus Laboratories Inc., 9410 Carroll Park Dr., San Diego, CA 92121. Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044. Valeant Pharmaceuticals Luxembourg S.a.r.l, C/O Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. E:\FR\FM\20JYN1.SGM 20JYN1 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices 42829 Application No. Drug Applicant ANDA 088762 .... PROMETH W/DEXTROMETHORPHAN (dextromethorphan hydrobromide; promethazine HCl) Syrup; Oral 15 mg/5 mL; 6.25 mg/5 mL. G&W Laboratories Inc.,111 Coolidge St., South Plainfield, NJ 07080. 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 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: July 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–17730 Filed 7–17–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Bioequivalence Recommendations for Lubiprostone; Revised Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lubiprostone capsules entitled ‘‘Bioequivalence Recommendations for Lubiprostone.’’ The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lubiprostone capsules. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:30 Jul 17, 2015 Jkt 235001 DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 18, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993–0002, 301–796–5850. SUPPLEMENTARY INFORMATION: capsules in January 2006. There are no approved ANDAs for this product. In August 2010, we issued a draft guidance for industry on BE recommendations for generic lubiprostone capsules. We are now issuing a revised draft guidance for industry on BE recommendations for generic lubiprostone capsules (‘‘Bioequivalence Recommendations for Lubiprostone’’). In January 2014, Sucampo Pharma Americas, LLC, manufacturer of the reference listed drug, AMITIZA, submitted a citizen petition requesting that FDA revise the BE requirements for any new drug product that references AMITIZA and seeks approval by means of demonstrating BE to AMITIZA. FDA has reviewed the issues raised in the petition and is responding to the petition (Docket No. FDA–2014–P– 0144). This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on the design of BE studies to support ANDAs for lubiprostone capsules. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make product-specific BE recommendations available to the public on FDA’s Web site at http://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate productspecific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of draft BE recommendations for lubiprostone capsules. FDA initially approved new drug application (NDA) 021908 for AMITIZA II. Comments PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. E:\FR\FM\20JYN1.SGM 20JYN1

Agencies

[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42828-42829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17730]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2412]


Determination That TESSALON (Benzonatate) Capsules 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) 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.

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 
sponsors 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. ANDAs 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. (As requested by the applicant, FDA withdrew 
approval of NDA 050448 for GRIFULVIN (griseofulvin) Oral Suspension in 
the Federal Register of August 16, 2001 (66 FR 43017)).

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 011210.............  TESSALON (benzonatate)   Pfizer Inc., 1 Giralda
                          Capsule; Oral 200        Farms, Madison, NJ
                          milligrams (mg).         07940.
NDA 012093.............  ISORDIL (isosorbide      Valeant
                          dinitrate) Tablet;       Pharmaceuticals North
                          Oral 10 mg, 20 mg, 30    America, LLC, 400
                          mg.                      Somerset Corporate
                                                   Blvd., Bridgewater,
                                                   NJ 08807.
NDA 018702.............  ACLOVATE (alclometasone  Fougera
                          dipropionate)            Pharmaceuticals Inc.,
                          Ointment; Topical        60 Baylis Rd., P.O.
                          0.05%.                   Box 2006, Melville,
                                                   NY 11747.
NDA 018707.............  ACLOVATE (alclometasone  Do.
                          dipropionate) Cream;
                          Topical 0.05%.
NDA 018936.............  SARAFEM (fluoxetine      Eli Lilly and Co.,
                          hydrochloride (HCl))     Lilly Corp. Ctr.,
                          Capsule; Oral            Indianapolis, IN
                          Equivalent to (EQ) 10    46285.
                          mg Base, EQ 20 mg Base.
NDA 018988.............  VASOCIDIN (prednisolone  Novartis
                          sodium phosphate;        Pharmaceuticals
                          sulfacetamide sodium),   Corp., 105 Eisenhower
                          Solution/Drops;          Pky., 280 Corporate
                          Ophthalmic, EQ 0.23%     Center, Roseland, NJ
                          phosphate; 10%.          07068.
NDA 019898.............  PRAVACHOL (pravastatin   Bristol-Myers Squibb
                          sodium) Tablet; Oral     Co., P.O. Box 4000,
                          10 mg.                   Princeton, NJ 08543-
                                                   4000.
NDA 020092.............  DILACOR XR (diltiazem    Actavis Laboratories
                          HCl) Capsule, Extended-  UT, Inc., 577 Chipeta
                          Release; Oral 120 mg,    Way, Salt Lake City,
                          180 mg, 240 mg.          UT 84108.
NDA 021551.............  HALFLYTELY               Braintree
                          (polyethylene glycol     Laboratories, Inc.,
                          3350; potassium          60 Columbia St., P.O.
                          chloride; sodium         Box 850929,
                          bicarbonate; sodium      Braintree, MA 02185.
                          chloride) For Solution
                          and bisacodyl Delayed-
                          Release Tablets); Oral
                          210 grams (g); 0.74 g;
                          2.86 g; 5.6 g; 5 mg.
NDA 021871.............  LOESTRIN 24 FE (ethinyl  Warner Chilcott Co.
                          estradiol;               LLC, Union Street Rd.
                          norethindrone acetate)   195 KM 1.1., Fajardo,
                          Tablet; Oral 0.02 mg;    Puerto Rico 00738.
                          1 mg.
NDA 050448.............  GRIFULVIN V              Johnson & Johnson
                          (griseofulvin,           Consumer Products
                          microcrystalline)        Co., 199 Grandview
                          Suspension; Oral 125     Rd., Skillman, NJ
                          mg/5 milliliters (mL).   08558.
NDA 050719.............  HELIDAC (bismuth         Prometheus
                          subsalicylate;           Laboratories Inc.,
                          metronidazole;           9410 Carroll Park
                          tetracycline HCl)        Dr., San Diego, CA
                          Tablet, Chewable,        92121.
                          Tablet, Capsule; Oral
                          262.4 mg; 250 mg, 500
                          mg.
ANDA 040454............  PROMETHAZINE             Teva Pharmaceuticals
                          HYDROCHLORIDE            USA, 425 Privet Rd.,
                          (promethazine HCl)       Horsham, PA 19044.
                          Injectable; Injection
                          25 mg/mL, 50 mg/mL.
ANDA 062483............  GRIFULVIN V              Valeant
                          (griseofulvin,           Pharmaceuticals
                          microsize) Suspension;   Luxembourg S.a.r.l, C/
                          Oral 125 mg/5 mL.        O Valeant
                                                   Pharmaceuticals North
                                                   America LLC, 400
                                                   Somerset Corporate
                                                   Blvd., Bridgewater,
                                                   NJ 08807.

[[Page 42829]]

 
ANDA 088762............  PROMETH W/               G&W Laboratories
                          DEXTROMETHORPHAN         Inc.,111 Coolidge
                          (dextromethorphan        St., South
                          hydrobromide;            Plainfield, NJ 07080.
                          promethazine HCl)
                          Syrup; Oral 15 mg/5
                          mL; 6.25 mg/5 mL.
------------------------------------------------------------------------

    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: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17730 Filed 7-17-15; 8:45 am]
 BILLING CODE 4164-01-P