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Notice

Determination That DIASTAT (Diazepam Rectal Gel), 5 Milligrams/Milliliter, 10 Milligrams/2 Milliliter, 15 Milligrams/3 Milliliter, and 20 Milligrams/4 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) has determined that DIASTAT (diazepam rectal gel) (DIASTAT), 5 milligrams (mg)/milliliter (mL), 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, was not withdrawn from sale for reasons of safety or effectiveness.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 diazepam rectal gel, 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, if all other legal and regulatory requirements are met.

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FOR FURTHER INFORMATION CONTACT:

Nikki Mueller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6312, Silver Spring, MD 20993-0002, 301-796-3601.

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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 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 removed from the list if the agency withdraws or suspends approval of the drug's NDA 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.

Lachman Consultant Services, Inc., submitted to FDA a citizen petition dated May 15, 2006 (Docket No. FDA-2006-P-0386),1 under 21 CFR 10.30 requesting that the agency determine whether DIASTAT (diazepam rectal gel), 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, was withdrawn from sale for reasons of safety or effectiveness. DIASTAT (diazepam rectal gel) is the subject of approved NDA 20-648 held by Valeant Pharmaceuticals International (Valeant) (formerly held by Xcel Pharmaceuticals). DIASTAT (diazepam rectal gel) is an anticonvulsant agent indicated for use in the management of selected, refractory patients with epilepsy, on stable regimens of antiepileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity.

DIASTAT (diazepam rectal gel) was approved on July 29, 1997 (NDA 20-648). On September 15, 2005, FDA approved a supplement (NDA 20-648/S-008) for a new delivery system of DIASTAT (diazepam rectal gel), marketed under the trade name DIASTAT ACUDIAL. Following approval of DIASTAT ACUDIAL, Valeant discontinued marketing DIASTAT (diazepam rectal gel) (NDA 20-648) in the 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL strengths, and those strengths of the product were moved to the “Discontinued Drug Product List” section of the Orange Book. We note that the original DIASTAT (diazepam rectal gel) and DIASTAT ACUDIAL that replaced the original DIASTAT delivery system contain the same diazepam gel formulation. Thus, the original diazepam gel formulation is still being marketed, but in a different delivery system.

After considering the citizen petitions, other information submitted to the docket, and reviewing our records, FDA has determined that DIASTAT (diazepam rectal gel), 5 mg/ mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, was not withdrawn from sale for reasons of safety or effectiveness. FDA has independently evaluated relevant literature and data for possible postmarketing adverse events and has found no information that would indicate that DIASTAT (diazepam rectal gel), 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, was withdrawn from sale for reasons of safety or effectiveness. Issues regarding the appropriateness of permitting ANDAs referencing the discontinued DIASTAT (diazepam rectal gel) to be marketed at the same time as DIASTAT ACUDIAL are being addressed in a separate docket (FDA-2006-P-0009).

Accordingly, the agency will continue to list DIASTAT (diazepam rectal gel), 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 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 or effectiveness. ANDAs that refer to DIASTAT (diazepam rectal gel), 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, may be approved by the agency if all other legal and regulatory requirements for the approval of ANDAs are met. 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.

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Dated: August 12, 2010.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning and Budget.

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Footnotes

1.  This citizen petition was originally assigned docket number 2006P-0209. The number changed to FDA-2006-P-0386 as a result of FDA's transition to its new docketing system (Regulations.gov) in January 2008.

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[FR Doc. 2010-20327 Filed 8-17-10; 8:45 am]

BILLING CODE 4160-01-S