[Federal Register Volume 71, Number 22 (Thursday, February 2, 2006)]
[Notices]
[Pages 5667-5668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1364]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005P-0096]


Determination That CLARITIN (Loratadine) Hives Relief Syrup, 5 
Milligrams per 5 Milliliters, Was Not Withdrawn From Sale for Reasons 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 
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milliliters (mL), was not withdrawn from sale for reasons of safety or 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.

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.

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 Under FDA regulations, drugs are withdrawn from the list if the 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 
(Sec.  314.162 (21 CFR 314.162)).
    Under Sec.  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

[[Page 5668]]

CLARITIN 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 Sec.  
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 Sec. Sec.  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.

    Dated: January 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1364 Filed 2-1-06; 8:45 am]
BILLING CODE 4160-01-S