80 FR 42828 - Determination That TESSALON (Benzonatate) Capsules and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 138 (July 20, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 138 (July 20, 2015)
| Page Range | 42828-42829 | |
| FR Document | 2015-17730 |
[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)] [Notices] [Pages 42828-42829] From the Federal Register Online [www.thefederalregister.org] [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[Docket No. FDA-2015-N-2412] Determination That TESSALON (Benzonatate) Capsules and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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
![42828 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices
Dated: July 15, 2015. meet relevant legal and regulatory which is generally known as the
Leslie Kux, requirements. ‘‘Orange Book.’’ Under FDA regulations,
Associate Commissioner for Policy. a drug is removed from the list if the
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–17729 Filed 7–17–15; 8:45 am] Agency withdraws or suspends
Stacy Kane, Center for Drug Evaluation
BILLING CODE 4164–01–P
approval of the drug’s NDA or ANDA
and Research, Food and Drug
for reasons of safety or effectiveness, or
Administration, 10903 New Hampshire
if FDA determines that the listed drug
Ave., Bldg. 51, Rm. 6207, Silver Spring,
DEPARTMENT OF HEALTH AND was withdrawn from sale for reasons of
MD 20993–0002, 301–796–8363.
HUMAN SERVICES safety or effectiveness (21 CFR 314.162).
SUPPLEMENTARY INFORMATION: In 1984, Under § 314.161(a) (21 CFR
Food and Drug Administration Congress enacted the Drug Price 314.161(a)), the Agency must determine
Competition and Patent Term whether a listed drug was withdrawn
[Docket No. FDA–2015–N–2412] Restoration Act of 1984 (Pub. L. 98–417) from sale for reasons of safety or
(the 1984 amendments), which effectiveness: (1) Before an ANDA that
Determination That TESSALON authorized the approval of duplicate refers to that listed drug may be
(Benzonatate) Capsules and Other versions of drug products approved approved, (2) whenever a listed drug is
Drug Products Were Not Withdrawn under an ANDA procedure. ANDA voluntarily withdrawn from sale and
From Sale for Reasons of Safety or sponsors must, with certain exceptions, ANDAs that refer to the listed drug have
Effectiveness show that the drug for which they are been approved, and (3) when a person
seeking approval contains the same petitions for such a determination under
AGENCY: Food and Drug Administration, active ingredient in the same strength 21 CFR 10.25(a) and 10.30. Section
HHS. and dosage form as the ‘‘listed drug,’’ 314.161(d) provides that if FDA
ACTION: Notice. which is a version of the drug that was determines that a listed drug was
previously approved. ANDAs applicants withdrawn from sale for safety or
SUMMARY: The Food and Drug do not have to repeat the extensive effectiveness reasons, the Agency will
Administration (FDA) has determined clinical testing otherwise necessary to initiate proceedings that could result in
that the drug products listed in this gain approval of a new drug application the withdrawal of approval of the
document were not withdrawn from (NDA). ANDAs that refer to the listed drug.
sale for reasons of safety or The 1984 amendments include what FDA has become aware that the drug
effectiveness. This determination means is now section 505(j)(7) of the Federal products listed in the table are no longer
that FDA will not begin procedures to Food, Drug, and Cosmetic Act (21 U.S.C. being marketed. (As requested by the
withdraw approval of abbreviated new 355(j)(7)), which requires FDA to applicant, FDA withdrew approval of
drug applications (ANDAs) that refer to publish a list of all approved drugs. NDA 050448 for GRIFULVIN
these drug products, and it will allow FDA publishes this list as part of the (griseofulvin) Oral Suspension in the
FDA to continue to approve ANDAs that ‘‘Approved Drug Products with Federal Register of August 16, 2001 (66
refer to the products as long as they Therapeutic Equivalence Evaluations,’’ FR 43017)).
Application No. Drug Applicant
NDA 011210 ...... TESSALON (benzonatate) Capsule; Oral 200 milligrams (mg) Pfizer Inc., 1 Giralda Farms, Madison, NJ 07940.
NDA 012093 ...... ISORDIL (isosorbide dinitrate) Tablet; Oral 10 mg, 20 mg, 30 Valeant Pharmaceuticals North America, LLC, 400 Somerset
mg. Corporate Blvd., Bridgewater, NJ 08807.
NDA 018702 ...... ACLOVATE (alclometasone dipropionate) Ointment; Topical Fougera Pharmaceuticals Inc., 60 Baylis Rd., P.O. Box 2006,
0.05%. Melville, NY 11747.
NDA 018707 ...... ACLOVATE (alclometasone dipropionate) Cream; Topical Do.
0.05%.
NDA 018936 ...... SARAFEM (fluoxetine hydrochloride (HCl)) Capsule; Oral Eli Lilly and Co., Lilly Corp. Ctr., Indianapolis, IN 46285.
Equivalent to (EQ) 10 mg Base, EQ 20 mg Base.
NDA 018988 ...... VASOCIDIN (prednisolone sodium phosphate; sulfacetamide Novartis Pharmaceuticals Corp., 105 Eisenhower Pky., 280
sodium), Solution/Drops; Ophthalmic, EQ 0.23% phos- Corporate Center, Roseland, NJ 07068.
phate; 10%.
NDA 019898 ...... PRAVACHOL (pravastatin sodium) Tablet; Oral 10 mg .......... Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543–4000.
NDA 020092 ...... DILACOR XR (diltiazem HCl) Capsule, Extended-Release; Actavis Laboratories UT, Inc., 577 Chipeta Way, Salt Lake
Oral 120 mg, 180 mg, 240 mg. City, UT 84108.
NDA 021551 ...... HALFLYTELY (polyethylene glycol 3350; potassium chloride; Braintree Laboratories, Inc., 60 Columbia St., P.O. Box
sodium bicarbonate; sodium chloride) For Solution and 850929, Braintree, MA 02185.
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 estradiol; norethindrone acetate) Warner Chilcott Co. LLC, Union Street Rd. 195 KM 1.1.,
Tablet; Oral 0.02 mg; 1 mg. Fajardo, Puerto Rico 00738.
NDA 050448 ...... GRIFULVIN V (griseofulvin, microcrystalline) Suspension; Johnson & Johnson Consumer Products Co., 199 Grandview
Oral 125 mg/5 milliliters (mL). Rd., Skillman, NJ 08558.
mstockstill on DSK4VPTVN1PROD with NOTICES
NDA 050719 ...... HELIDAC (bismuth subsalicylate; metronidazole; tetracycline Prometheus Laboratories Inc., 9410 Carroll Park Dr., San
HCl) Tablet, Chewable, Tablet, Capsule; Oral 262.4 mg; Diego, CA 92121.
250 mg, 500 mg.
ANDA 040454 .... PROMETHAZINE HYDROCHLORIDE (promethazine HCl) Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA
Injectable; Injection 25 mg/mL, 50 mg/mL. 19044.
ANDA 062483 .... GRIFULVIN V (griseofulvin, microsize) Suspension; Oral 125 Valeant Pharmaceuticals Luxembourg S.a.r.l, C/O Valeant
mg/5 mL. Pharmaceuticals North America LLC, 400 Somerset Cor-
porate Blvd., Bridgewater, NJ 08807.
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![Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices 42829
Application No. Drug Applicant
ANDA 088762 .... PROMETH W/DEXTROMETHORPHAN (dextromethorphan G&W Laboratories Inc.,111 Coolidge St., South Plainfield, NJ
hydrobromide; promethazine HCl) Syrup; Oral 15 mg/5 mL; 07080.
6.25 mg/5 mL.
FDA has reviewed its records and, DATES: Although you can comment on capsules in January 2006. There are no
under § 314.161, has determined that any guidance at any time (see 21 CFR approved ANDAs for this product. In
the drug products listed in this 10.115(g)(5)), to ensure that the Agency August 2010, we issued a draft guidance
document were not withdrawn from considers your comments on this draft for industry on BE recommendations for
sale for reasons of safety or guidance before it begins work on the generic lubiprostone capsules. We are
effectiveness. Accordingly, the Agency final version of the guidance, submit now issuing a revised draft guidance for
will continue to list the drug products either electronic or written comments industry on BE recommendations for
listed in this document in the on the draft guidance by September 18, generic lubiprostone capsules
‘‘Discontinued Drug Product List’’ 2015. (‘‘Bioequivalence Recommendations for
section of the Orange Book. The ADDRESSES: Submit written requests for Lubiprostone’’).
‘‘Discontinued Drug Product List’’ single copies of the draft guidance to the In January 2014, Sucampo Pharma
identifies, among other items, drug Division of Drug Information, Center for Americas, LLC, manufacturer of the
products that have been discontinued Drug Evaluation and Research, Food reference listed drug, AMITIZA,
from marketing for reasons other than and Drug Administration, 10001 New submitted a citizen petition requesting
safety or effectiveness. Hampshire Ave., Hillandale Building, that FDA revise the BE requirements for
Approved ANDAs that refer to the 4th Floor, Silver Spring, MD 20993– any new drug product that references
NDAs and ANDAs listed in this 0002. Send one self-addressed adhesive AMITIZA and seeks approval by means
document are unaffected by the label to assist that office in processing of demonstrating BE to AMITIZA. FDA
discontinued marketing of the products your requests. See the SUPPLEMENTARY has reviewed the issues raised in the
subject to those NDAs and ANDAs. INFORMATION section for electronic petition and is responding to the
Additional ANDAs that refer to these access to the draft guidance document. petition (Docket No. FDA–2014–P–
products may also be approved by the Submit electronic comments on the 0144).
Agency if they comply with relevant draft guidance to http://
legal and regulatory requirements. If www.regulations.gov. Submit written This draft guidance is being issued
FDA determines that labeling for these comments to the Division of Dockets consistent with FDA’s good guidance
drug products should be revised to meet Management (HFA–305), Food and Drug practices regulation (21 CFR 10.115).
current standards, the Agency will Administration, 5630 Fishers Lane, Rm. The draft guidance, when finalized, will
advise ANDA applicants to submit such 1061, Rockville, MD 20852. represent the Agency’s current thinking
labeling. on the design of BE studies to support
FOR FURTHER INFORMATION CONTACT:
ANDAs for lubiprostone capsules. It
Dated: July 15, 2015. Xiaoqiu Tang, Center for Drug does not create or confer any rights for
Leslie Kux, Evaluation and Research (HFD–600), or on any person and does not operate
Associate Commissioner for Policy. Food and Drug Administration, 10903 to bind FDA or the public. An
[FR Doc. 2015–17730 Filed 7–17–15; 8:45 am]
New Hampshire Ave., Bldg. 75, Rm. alternative approach may be used if
4730, Silver Spring, MD 20993–0002, such approach satisfies the
BILLING CODE 4164–01–P
301–796–5850. requirements of the applicable statutes
SUPPLEMENTARY INFORMATION: and regulations.
DEPARTMENT OF HEALTH AND I. Background
HUMAN SERVICES II. Comments
In the Federal Register of June 11,
Food and Drug Administration 2010 (75 FR 33311), FDA announced the Interested persons may submit either
availability of a guidance for industry, electronic comments regarding this
[Docket No. FDA–2007–D–0369] ‘‘Bioequivalence Recommendations for document to http://www.regulations.gov
Specific Products,’’ which explained the or written comments to the Division of
Bioequivalence Recommendations for Dockets Management (see ADDRESSES). It
Lubiprostone; Revised Draft Guidance process that would be used to make
product-specific BE recommendations is only necessary to send one set of
for Industry; Availability comments. Identify comments with the
available to the public on FDA’s Web
AGENCY: Food and Drug Administration, site at http://www.fda.gov/Drugs/ docket number found in brackets in the
HHS. GuidanceComplianceRegulatory heading of this document. Received
Information/Guidances/default.htm. As comments may be seen in the Division
ACTION: Notice.
described in that guidance, FDA of Dockets Management between 9 a.m.
SUMMARY: The Food and Drug adopted this process as a means to and 4 p.m., Monday through Friday, and
Administration (FDA) is announcing the develop and disseminate product- will be posted to the docket at http://
availability of a revised draft guidance specific BE recommendations and www.regulations.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
for industry on lubiprostone capsules provide a meaningful opportunity for III. Electronic Access
entitled ‘‘Bioequivalence the public to consider and comment on
Recommendations for Lubiprostone.’’ those recommendations. This notice Persons with access to the Internet
The recommendations provide specific announces the availability of draft BE may obtain the document at either
guidance on the design of recommendations for lubiprostone http://www.fda.gov/Drugs/Guidance
bioequivalence (BE) studies to support capsules. ComplianceRegulatoryInformation/
abbreviated new drug applications FDA initially approved new drug Guidances/default.htm or http://
(ANDAs) for lubiprostone capsules. application (NDA) 021908 for AMITIZA www.regulations.gov.
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Document Created: 2015-12-15 12:57:52
Document Modified: 2015-12-15 12:57:52
| 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. | |
| FR Citation | 80 FR 42828 |
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