Drug Products Not Withdrawn from Sale for Reasons of Safety or Effectiveness: MICARDIS (Telmisartan), Tablets, 20 Milligrams and 80 Milligrams

Determination That MICARDIS (Telmisartan), Tablets, 20 Milligrams and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161). FDA may not approve an ANDA that does not refer to a listed drug.

MICARDIS (telmisartan), tablets, 20 mg and 80 mg, are the subject of NDA 020850, held by Boehringer Ingelheim. NDA 020850 was initially approved on November 10, 1998. MICARDIS is indicated for the treatment of hypertension, to lower blood pressure and for cardiovascular risk reduction in patients unable to take ACE inhibitors.

MICARDIS (telmisartan), tablets, 20 mg and 80 mg, are currently listed in the "Discontinued Drug Product List" section of the Orange Book.

Unichem Pharmaceuticals (USA), Inc. submitted a citizen petition dated December 12, 2025 (Docket No. FDA-2025-P-7054), under 21 CFR 10.30, requesting that the Agency determine whether MICARDIS (telmisartan), tablets, 20 mg and 80 mg, were voluntarily 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 MICARDIS (telmisartan), tablets, 20 mg and 80 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that these drug products were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of MICARDIS (telmisartan), tablets, 20 mg and 80 mg, 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 MICARDIS (telmisartan), tablets, 20 mg and 80 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. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to these drug products. Additional ANDAs for these drug products 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 these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.