Document ID: FDA-2015-N-2412-0001
Agency: fda
Document Type: Notice
Title: Determination That TESSALON (Benzonatate) Capsules and Other
Drug Products Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
Posted Date: 2015-07-20T04:00Z

[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]

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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Products Were Not Withdrawn From Sale for Reasons of Safety or 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.

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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drug products listed in this document were not withdrawn from sale for 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