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Notice

Determination That CLARITIN (Loratadine) Hives Relief Syrup, 5 Milligrams per 5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) has determined that CLARITIN (loratadine) Hives Relief syrup, 5 milligrams (mg) per (/) 5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for loratadine hives relief syrup, 5 mg/5mL.

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FOR FURTHER INFORMATION CONTACT:

Tawni B. Schwemer, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

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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 typically a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug.

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 Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (§ 314.162 (21 CFR 314.162)).

Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug.

CLARITIN (loratadine) Hives Relief syrup, 5 mg/5 mL, is the subject of approved NDA 20-641 held by Schering Corp. (now Schering-Plough Healthcare Products) (Schering). In January 2002, Schering submitted a supplemental NDA for the over-the-counter (OTC) use of CLARITIN (loratadine) syrup for the relief of itching due to hives (urticaria), to be marketed under the trade name Start Printed Page 5668CLARITIN Hives Relief. FDA approved this trade name and indication for OTC use under NDA 20-641 on November 19, 2003. Schering has not marketed the 5-mg/5-mL strength of Claritin Hives Relief syrup.

In a citizen petition dated February 23, 2005 (Docket No. 2005P-0096), submitted under 21 CFR 10.30, Silarx Pharmaceuticals, Inc. (Silarx), requested that the agency determine, as described in § 314.161, whether CLARITIN (loratadine) Hives Relief syrup, 5 mg/5 mL, was withdrawn from sale for reasons of safety or effectiveness. The agency has determined that Schering's CLARITIN (loratadine) Hives Relief syrup, 5 mg/5 mL, approved under NDA 20-641, was not withdrawn from sale for reasons of safety or effectiveness. To date, Schering has not marketed the 5-mg/5-mL strength of its CLARITIN (loratadine) Hives Relief syrup. In previous instances (see e.g., the Federal Register of December 30, 2002 (67 FR 79640 at 79641) (addressing a relisting request for Diazepam Autoinjector)), the agency has determined that, for purposes of §§ 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale.

FDA has reviewed its files for records concerning the withdrawal of CLARITIN (loratadine) Hives Relief syrup, 5 mg/5 mL. There is no indication that the decision not to market CLARITIN (loratadine) Hives Relief syrup, 5 mg/5 mL, commercially is a function of safety or effectiveness concerns, and no data or information has been submitted to the docket concerning the reason for which CLARITIN (loratadine) Hives Relief syrup, 5 mg/5 mL was withdrawn from sale. The identical formulation and strength is currently marketed OTC as Claritin syrup for the temporary relief of symptoms due to hay fever or other respiratory allergies: runny nose, sneezing, itching, watery eyes, and itching of the nose or throat. FDA is not aware of information that would indicate that Claritin Hives Relief syrup was withdrawn from sale for reasons of safety or effectiveness.

For the reasons outlined in this document, FDA has determined that Schering's CLARITIN (loratadine) Hives Relief syrup, 5 mg/5 mL, was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list CLARITIN (loratadine) Hives Relief syrup, 5 mg/5 mL, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety and effectiveness. ANDAs that refer to CLARITIN (loratadine) Hives Relief syrup, 5 mg/5 mL, may be approved by the agency.

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Dated: January 24, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E6-1364 Filed 2-1-06; 8:45 am]

BILLING CODE 4160-01-S