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Determination That TESSALON (Benzonatate) Capsules and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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.

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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.

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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of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily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.DrugApplicant
NDA 011210TESSALON (benzonatate) Capsule; Oral 200 milligrams (mg)Pfizer Inc., 1 Giralda Farms, Madison, NJ 07940.
NDA 012093ISORDIL (isosorbide dinitrate) Tablet; Oral 10 mg, 20 mg, 30 mgValeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
NDA 018702ACLOVATE (alclometasone dipropionate) Ointment; Topical 0.05%Fougera Pharmaceuticals Inc., 60 Baylis Rd., P.O. Box 2006, Melville, NY 11747.
NDA 018707ACLOVATE (alclometasone dipropionate) Cream; Topical 0.05%Do.
NDA 018936SARAFEM (fluoxetine hydrochloride (HCl)) Capsule; Oral Equivalent to (EQ) 10 mg Base, EQ 20 mg BaseEli Lilly and Co., Lilly Corp. Ctr., Indianapolis, IN 46285.
NDA 018988VASOCIDIN (prednisolone sodium phosphate; sulfacetamide sodium), Solution/Drops; Ophthalmic, EQ 0.23% phosphate; 10%Novartis Pharmaceuticals Corp., 105 Eisenhower Pky., 280 Corporate Center, Roseland, NJ 07068.
NDA 019898PRAVACHOL (pravastatin sodium) Tablet; Oral 10 mgBristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000.
NDA 020092DILACOR XR (diltiazem HCl) Capsule, Extended-Release; Oral 120 mg, 180 mg, 240 mgActavis Laboratories UT, Inc., 577 Chipeta Way, Salt Lake City, UT 84108.
NDA 021551HALFLYTELY (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 mgBraintree Laboratories, Inc., 60 Columbia St., P.O. Box 850929, Braintree, MA 02185.
NDA 021871LOESTRIN 24 FE (ethinyl estradiol; norethindrone acetate) Tablet; Oral 0.02 mg; 1 mgWarner Chilcott Co. LLC, Union Street Rd. 195 KM 1.1., Fajardo, Puerto Rico 00738.
NDA 050448GRIFULVIN V (griseofulvin, microcrystalline) Suspension; Oral 125 mg/5 milliliters (mL)Johnson & Johnson Consumer Products Co., 199 Grandview Rd., Skillman, NJ 08558.
NDA 050719HELIDAC (bismuth subsalicylate; metronidazole; tetracycline HCl) Tablet, Chewable, Tablet, Capsule; Oral 262.4 mg; 250 mg, 500 mgPrometheus Laboratories Inc., 9410 Carroll Park Dr., San Diego, CA 92121.
ANDA 040454PROMETHAZINE HYDROCHLORIDE (promethazine HCl) Injectable; Injection 25 mg/mL, 50 mg/mLTeva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044.
ANDA 062483GRIFULVIN V (griseofulvin, microsize) Suspension; Oral 125 mg/5 mLValeant Pharmaceuticals Luxembourg S.a.r.l, C/O Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
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ANDA 088762PROMETH W/DEXTROMETHORPHAN (dextromethorphan hydrobromide; promethazine HCl) Syrup; Oral 15 mg/5 mL; 6.25 mg/5 mLG&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.

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Dated: July 15, 2015.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2015-17730 Filed 7-17-15; 8:45 am]