FDA daily

FDA daily for Friday, August 14, 2026

In this issue: 2 shortage updates, 19 approvals, 16 device recalls, 47 device decisions, 144 label changes and a new batch of complete response letters. 2 items touch categories MedGrid carries, and they come first.

For MedGrid's categories

Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.

Drug shortages

FDA date:

FDA updated 2 shortage entries on Thu, Aug 13: 2 new, 2 to be discontinued.

Browse drug shortages in FDA data →

Drug and biologic approvals

FDA date:

On Fri, Aug 7 FDA approved 3 new applications (0 brand or biologic, 3 generic) and 16 supplements to existing ones.

Browse drug and biologic approvals in FDA data →

Device recalls

FDA date:

FDA posted 16 device recalls from 8 firms on Fri, Aug 7.

Browse device recalls in FDA data →

Device clearances and approvals

FDA date:

FDA decided 24 510(k)s and 23 PMA decisions on Fri, Jul 31.

Browse device clearances and approvals in FDA data →

Label updates

FDA date:

144 drug labels took effect on Fri, Jul 31; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.

  • Continuous Correction Cream

    TITANIUM DIOXIDE · Baxter of California, LLC · TOPICAL

    Sunscreen & SPFHUMAN OTC DRUG
  • Haloperidol

    HALOPERIDOL · REMEDYREPACK INC. · ORAL

    Boxed warningHUMAN PRESCRIPTION DRUG
  • Aripiprazole

    ARIPIPRAZOLE · REMEDYREPACK INC. · ORAL

    Boxed warningHUMAN PRESCRIPTION DRUG
  • ITRACONAZOLE

    ITRACONAZOLE · Alembic Pharmaceuticals Inc. · ORAL

    Boxed warningHUMAN PRESCRIPTION DRUG
Browse label updates in FDA data →

Complete response letters

FDA date:

FDA published a new batch of complete response letters, the letters that explain why an application was not approved as submitted. 2026 now has 32 letters; the newest are below.

  • ITM Solucin GmbH · NDA 218705

    g U.S. FOOD & DRUG Naty ADMINISTRATION NDA 218705 COMPLETE RESPONSE ITM Solucin GmbH c/o Lumara Bio USA Inc. Attention: Tinya Sow, MHA US Agent, Director - US, Regulatory Lead 5 Vaughn Drive, Suite 3…

    COMPLETE RESPONSEUnapproved
  • Apiject Systems Corp. · NDA 219107

    PN U.S. FOOD & DRUG ADMINISTRATION NDA 219107 COMPLETE RESPONSE Apiject Systems Corp. Attention: Ashley Dynan Senior Director of Regulatory Affairs 2 High Ridge Park Stamford, CT 06905 Dear Ashley Dy…

    COMPLETE RESPONSEUnapproved
  • Elevar Therapeutics Inc. · NDA 216586

    i Lk YN U.S. FOOD & DRUG ADMINISTRATION NDA 216586 COMPLETE RESPONSE Elevar Therapeutics Inc. ATTENTION: Young-Sil (Anna) Yim Executive Director, Regulatory Affairs: 1 Bridge Plaza North, Suite 850 F…

    COMPLETE RESPONSEUnapproved
  • Jiangsu Hengrui Pharmaceuticals Co., Ltd. · BLA 761308

    yy U.S. FOOD & DRUG ADMINISTRATION BLA 761308 COMPLETE RESPONSE Jiangsu Hengrui Pharmaceuticals Co., Ltd. c/o Hengrui U.S.A., Inc. Attention: Brahmaiah Kommanaboyina US Agent Head of U.S. Regulatory…

    COMPLETE RESPONSEUnapproved
  • Ascelia Pharma AB · NDA 220544

    yy U.S. FOOD & DRUG ADMINISTRATION NDA 220544 COMPLETE RESPONSE Ascelia Pharma AB c/o Syneos Health Attention: Anju Mainra Senior Director Global Regulatory Affairs Solutions 1030 Sync Street Morrisv…

    COMPLETE RESPONSEUnapproved
  • Ipsen Biopharm Ltd. · BLA 761311

    nN U.S. FOOD & DRUG ADMINISTRATION BLA 761311 COMPLETE RESPONSE Ipsen Biopharm Ltd. C/O Galderma Research and Development, Inc. Attention: Chase Edwards Director, Regulatory Affairs 2001 Ross Ave Sui…

    COMPLETE RESPONSEUnapproved
  • Unicycive Therapeutics Inc. · NDA 218607

    yy U.S. FOOD & DRUG ADMINISTRATION NDA 218607 COMPLETE RESPONSE Unicycive Therapeutics Inc. Attention: Shalabh Gupta, MD, MPA President & CEO 1975 W. El Camino Real, Suite 204 Mountain View, CA 94040…

    COMPLETE RESPONSEUnapproved
  • Swedish Orphan Biovitrum AB (publ) · BLA 761438

    g U.S. FOOD & DRUG x ADMINISTRATION BLA 761438 COMPLETE RESPONSE Swedish Orphan Biovitrum AB (publ) Attention: Bao Le US Regulatory Lead, Immunology 77 4th Avenue, 3 Floor Waltham, MA 02451 Dear Bao…

    COMPLETE RESPONSEUnapproved
  • Evergreen Theragnostics, Inc. · NDA 216900

    PN U.S. FOOD & DRUG ADMINISTRATION NDA 216900 COMPLETE RESPONSE Evergreen Theragnostics, Inc. C/o Bourque Regulatory CMC, Inc. Attention: Mr. Jeffrey Bourque President, Bourque Regulatory CMC, Inc. 2…

    COMPLETE RESPONSEUnapprovedCenter for Drug Evaluation and Research,Food and Drug Administration
  • Tanvex BioPharma USA, Inc. · BLA 761266

    i Lk YN U.S. FOOD & DRUG ADMINISTRATION BLA 761266 COMPLETE RESPONSE Tanvex BioPharma USA, Inc. Attention: Bonnie J. Mills, PhD 10394 Pacific Center Court San Diego, CA 92121 Dear Dr. Mills: Please r…

    COMPLETE RESPONSEUnapproved
Browse complete response letters in FDA data →

How the FDA daily is written

Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.