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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2010-P-0338]

# AGENCY:

 Food and Drug Administration, HHS.

# ACTION:

 Notice.

# SUMMARY:

 The Food and Drug Administration (FDA) has determined that AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 milligrams (mg)/500 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for hydrocodone bitartrate and aspirin tablet, 5 mg/500 mg, if all other legal and regulatory requirements are met.

# FOR FURTHER INFORMATION CONTACT:

 Deborah Livornese, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6306, Silver Spring, MD 20993-0002, 301-796-0719.

# SUPPLEMENTARY INFORMATION:

                    In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA                           ( print page 61504)                        applicants 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. ANDA applicants 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 known generally as the “Orange Book.” Under FDA regulations, drugs are 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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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)(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.

AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, is the subject of ANDA 89-420, held by Schwarz Pharma, Inc., and initially approved on January 25, 1988. AZDONE is indicated for the relief of moderate to moderately severe pain. AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg is currently listed in the “Discontinued Drug Product List” section of the Orange Book.

Lachman Consultant Services, Inc., submitted a citizen petition dated June 23, 2010 (Docket No. FDA-2010-P-0338), under 21 CFR 10.30, requesting that the Agency determine whether AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, was withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records, FDA has determined under § 314.161 that AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events and have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, 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 or effectiveness. ANDAs that refer to AZDONE (hydrocodone bitartrate and aspirin) Tablet, 5 mg/500 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

Dated: September 29, 2010.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning and Budget.

[FR Doc. 2010-24902 Filed 10-4-10; 8:45 am]

BILLING CODE 4160-01-S