2023-24506. Determination That FORADIL (Formoterol Fumarate) Inhalation Powder, 0.012 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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, the Agency, or we) has determined that FORADIL (formoterol fumarate) inhalation powder, 0.012 milligrams (mg)/inhalation (inh), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for formoterol fumarate inhalation powder, 0.012 mg/inh, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:

Joe Thomas, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993–0002, 202–815–5571, [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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)).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.

FORADIL (formoterol fumarate) inhalation powder, 0.012 mg/inh, is the subject of NDA 020831, held by Novartis Pharmaceuticals Corp., and initially approved on February 16, 2001. FORADIL is indicated for treatment of asthma in patients 5 years of age and older as an add-on to a long-term asthma control medication such as an inhaled corticosteroid; prevention of exercise-induced bronchospasm (EIB) in patients 5 years of age and older; and maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease.

In a letter dated September 30, 2015, Novartis Pharmaceuticals Corp. notified FDA that FORADIL (formoterol fumarate) inhalation powder, 0.012 mg/inh, was being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book. In the Federal Register of June 21, 2018 (83 FR 28856), FDA announced that it was withdrawing approval of NDA 020831, effective July 23, 2018.

K&L Gates LLP submitted a citizen petition dated June 21, 2023 (Docket No. FDA–2023–P–2536), under 21 CFR 10.30, requesting that the Agency determine whether FORADIL (formoterol fumarate) inhalation powder, 0.012 mg/inh, 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 FORADIL (formoterol fumarate) inhalation powder, 0.012 mg/inh, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that FORADIL (formoterol fumarate) inhalation powder, 0.012 mg/inh, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of FORADIL (formoterol fumarate) inhalation powder, 0.012 mg/inh, 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 FORADIL (formoterol fumarate) inhalation powder, 0.012 mg/inh, 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. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also 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: November 1, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.