Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) has determined that STRATTERA (atomoxetine hydrochloride) capsules 5 milligrams, 10 milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, were not withdrawn from sale for reasons of safety or effectiveness.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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2025-P-6868] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that STRATTERA (atomoxetine hydrochloride) capsules 5 milligrams, 10 milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, were not withdrawn from sale for reasons of safety or effectiveness.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: Rana Carroll, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6218, Silver Spring, MD 20993-0002, 301-796-6135, Rana.Carroll@fda.hhs.gov . 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, w…
Citation: 91 FR 17285
