Determination That CLARITIN (Loratadine) Hives Relief Syrup, 5 Milligrams per 5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 5667-5668 [E6-1364]

Download as PDF Federal Register / Vol. 71, No. 22 / Thursday, February 2, 2006 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. hsrobinson on PROD1PC71 with NOTICES SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for INVANZ (ertapenem), KEPPRA (levetiracetam), TRILEPTAL (Oxcarbazepine), and ZYVOX (linezolid). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement. ADDRESSES: Submit written requests for single copies of the summaries to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Please specify by product name which summary or summaries you are requesting. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries. FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 1613, Silver Spring, MD 20993-0002, 301– 796–2200, carmouzeg@cder.fda.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies conducted for INVANZ (ertapenem), KEPPRA (levetiracetam), TRILEPTAL (Oxcarbazepine), and ZYVOX (linezolid). The summaries are being made available consistent with section 9 of the BPCA (Public Law 107– 109). Enacted on January 4, 2002, the BPCA reauthorizes, with certain important changes, the pediatric exclusivity program described in section 505A of the Federal Food, Drug, and VerDate Aug<31>2005 15:26 Feb 01, 2006 Jkt 208001 Cosmetic Act (21 U.S.C. 355a). Section 505A permits certain applications to obtain 6 months of marketing exclusivity if, in accordance with the requirements of the statute, the sponsor submits requested information relating to the use of the drug in the pediatric population. One of the provisions the BPCA added to the pediatric exclusivity program pertains to the dissemination of pediatric information. Specifically, for all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of pediatric studies conducted for the supplement (21 U.S.C. 355a(m)(1)). The summaries are to be made available not later than 180 days after the report on the pediatric study is submitted to FDA (21 U.S.C. 355a(m)(1)). Consistent with this provision of the BPCA, FDA has posted on the Internet at https://www.fda.gov/ cder/pediatric/index.htm summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for INVANZ (ertapenem), KEPPRA (levetiracetam), TRILEPTAL (Oxcarbazepine), and ZYVOX (linezolid). Copies are also available by mail (see ADDRESSES). II. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/cder/pediatric/index.htm. Dated: January 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–1366 Filed 2–1–06; 8:45 am] BILLING CODE 4160–01–S 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. 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 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 5667 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 (§ 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 E:\FR\FM\02FEN1.SGM 02FEN1 hsrobinson on PROD1PC71 with NOTICES 5668 Federal Register / Vol. 71, No. 22 / Thursday, February 2, 2006 / Notices 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 § 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 5mg/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 VerDate Aug<31>2005 15:26 Feb 01, 2006 Jkt 208001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004E–0394] Determination of Regulatory Review Period for Purposes of Patent Extension; ALOXI AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for ALOXI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of Regulatory Policy (HFD–013), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240–453–6681. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted, as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product ALOXI (palonosetron hydrochloride). ALOXI is indicated for the following: (1) The prevention of acute nausea and vomiting associated with initial or repeat courses of moderately and highly emetogenic cancer chemotherapy, and (2) the prevention of delayed nausea and vomiting associated with initial or repeat courses of moderately and highly emetogenic cancer chemotherapy. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for ALOXI (U.S. Patent No. 5,202,333) from Roche Palo Alto, LLC, and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated October 19, 2004, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of ALOXI represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for ALOXI is 3,867 days. Of this time, 3,565 days occurred during the testing phase of the regulatory review period, while 302 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: December 24, 1992. The applicant claims December 22, 1992, as the date the investigational new drug application (IND) became effective. However, FDA records E:\FR\FM\02FEN1.SGM 02FEN1

Agencies

[Federal Register Volume 71, Number 22 (Thursday, February 2, 2006)]
[Notices]
[Pages 5667-5668]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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

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