The United States Food and Drug Administration (FDA) has reviewed your firm’s listing information provided for Fenofibrate 48mg, NDC 43353-248, and Montelukast Sodium, NDC 43353-252. Our review revealed that the listings for these products include inaccurate information. You have failed to address these listing deficiencies detailed in FDA’s letters to your company dated Aug. 24, 2017 and Oct. 12, 2017. Prompt action must be taken to correct these deficiencies.
Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) outlines the requirements for registration and listing of drug products. In accordance with these requirements, the listing for Fenofibrate 48mg, NDC 43353-248, and Montelukast Sodium, NDC 43353-252, must include “a copy of all labeling for such drug.” A review of the product listing for Fenofibrate 48mg, NDC 43353-248, reveals that it does not include a correct copy of the carton label. Specifically, the image uploaded into the FDA’s Electronic Drug Registration and Listing System (eDRLS) does not appear to be an image of your product’s label. The strength listed in the electronic listing submission is for Fenofibrate 48 mg, but the carton label included corresponds to Fenofibrate 145 mg.
Similarly, a review of the product listing for Montelukast Sodium, NDC 43353-252, reveals that it does not include a correct copy of the carton label. The image uploaded into eDRLS does not appear to be an image of your product’s label. The strength listed in the electronic listing submission is for Montelukast Sodium 5 mg but the carton label included corresponds to Montelukast Sodium 10 mg.
Your firm failed to fulfill its listing obligations under Section 510(j) of the FD&C Act, which is prohibited under Section 301(p) of the FD&C Act. Such failure misbrands the products under Section 502(o) of the FD&C Act, and introduction or delivery for introduction into interstate commerce of a misbranded product is prohibited under Section 301(a) of the FD&C Act.
Information from your firm’s registration and product listings is accessible not only to FDA, but to other interested parties, including consumers. The listing data for both products have been removed from the FDA’s online NDC Directory and will not be available for public viewing until the corrections are made. This is in an effort to maintain an accurate database to protect and promote the public health.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. Your response should include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete these corrective actions within fifteen (15) working days, state the reason for the delay and the date by which you will have completed the corrections. Please note that for revised SPLs submissions to be accepted, manual overrides may be required for certain types of errors. If you receive validation errors, or have any questions regarding the contents of this letter, please contact us at firstname.lastname@example.org for further assistance. Include the case identification numbers of 1161 and 1190 on all correspondences.
Your reply should be sent to:
Tasneem Hussain Pharm. D.
Food and Drug Administration
Mail Stop HFD-300
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Building 51 Room 2261
Finally, please be aware that this letter is not intended to be an all-inclusive list of the listing violations found in your firm’s registration and product listings. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Maria Rossana R. Cook
New Orleans District Office
 See FD&C Act § 510(j)(1)(A), 21 CFR 207.49(a)(15)(iv).