2024-23811. Determination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Department of Health and Human Services

Food and Drug Administration

1. [Docket No. FDA-2024-P-4163]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA, Agency, or we) has determined that NOXAFIL (posaconazole) delayed-release tablets, 100 grams (g), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT:

Awo Archampong-Gray, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New ( print page 83505) Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-796-0110, [e-mail].

SUPPLEMENTARY INFORMATION:

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

Section 505(j)(7) of the FD&C Act 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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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.

NOXAFIL (posaconazole) delayed-release tablets, 100 g, is the subject of NDA 205053, held by Merck Sharp & Dohme Corp., and initially approved on November 25, 2013. Noxafil delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. In addition, NOXAFIL is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows; for NOXAFIL delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kilograms.

NOXAFIL (posaconazole) delayed-release tablets, 100 g, is currently listed in the “Discontinued Drug Product List” section of the Orange Book.

Aizant Drug Research Solutions Private Limited, submitted a citizen petition dated September 2, 2024 (Docket No. FDA-2024-P-4163), and amended on September 4, 2024, under 21 CFR 10.30, requesting that the Agency determine whether NOXAFIL (posaconazole) delayed-release tablets, NDA 205053 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 NOXAFIL (posaconazole) delayed-release tablets, 100 g, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that NOXAFIL (posaconazole) delayed-release tablets, 100 g, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of NOXAFIL (posaconazole) delayed-release tablets, 100 g, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list NOXAFIL (posaconazole) delayed-release tablets, 100 g, 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. 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: October 9, 2024.

Eric Flamm,

Acting Associate Commissioner for Policy.