2021-10593. Determination That AVACLYR (Acyclovir Ophthalmic Ointment), 3 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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and Drug Administration (FDA or Agency) has determined that AVACLYR (acyclovir ophthalmic ointment), 3 percent, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for acyclovir ophthalmic ointment, 3 percent, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:

Nisha Shah, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455, [e-mail].

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 under an ANDA procedure. ANDA 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 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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

AVACLYR (acyclovir ophthalmic ointment), 3 percent, is the subject of NDA 202408, held by Fera Pharmaceuticals, LLC, and initially approved on March 29, 2019. AVACLYR is indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus.

In a letter dated August 21, 2019, Fera Pharmaceuticals, LLC notified FDA that AVACLYR (acyclovir ophthalmic ointment), 3 percent, was being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book.

Cumulus Pharmaceutical LLC submitted a citizen petition dated February 23, 2021, (Docket No. FDA-2021-P-0226), under 21 CFR 10.30, requesting that the Agency determine whether AVACLYR (acyclovir ophthalmic ointment), 3 percent, was withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that AVACLYR (acyclovir ophthalmic ointment), 3 percent, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that AVACLYR (acyclovir ophthalmic ointment), 3 percent, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of AVACLYR (acyclovir ophthalmic ointment), 3 percent, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list AVACLYR (acyclovir ophthalmic ointment), 3 percent, 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. Any ANDAs referencing AVACLYR (acyclovir ophthalmic ointment), 3 percent, 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: May 14, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.