FDA daily

FDA daily for Tuesday, April 8, 2025

In this issue: 11 approvals, 1 device recall, 9 device decisions and 106 label changes. 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 and biologic approvals

FDA date:

On Tue, Apr 1 FDA approved no new applications and 11 supplements to existing ones.

  • STELARA

    CENTOCOR ORTHO BIOTECH INC · USTEKINUMAB

    BLA125261Biologic (BLA)Prescription
  • DOXYCYCLINE HYCLATE

    SUN PHARM INDUSTRIES · DOXYCYCLINE HYCLATE

    ANDA062676Generic (ANDA)Prescription
  • NICOTINE POLACRILEX

    PERRIGO R AND D · NICOTINE POLACRILEX

    ANDA077007Generic (ANDA)Over-the-counter
  • DOXYCYCLINE HYCLATE

    SUN PHARM INDUSTRIES · DOXYCYCLINE HYCLATE

    ANDA062677Generic (ANDA)Prescription
  • ADZENYS XR-ODT

    NEOS THERAPS · AMPHETAMINE

    NDA204326Drug (NDA)Prescription
  • DOXYCYCLINE HYCLATE

    SUN PHARM INDUSTRIES · DOXYCYCLINE HYCLATE

    ANDA065134Generic (ANDA)Prescription
Browse drug and biologic approvals in FDA data →

Device recalls

FDA date:

FDA posted 1 device recall from 1 firm on Tue, Apr 1.

Browse device recalls in FDA data →

Device clearances and approvals

FDA date:

FDA decided 2 510(k)s and 7 PMA decisions on Tue, Mar 25.

Browse device clearances and approvals in FDA data →

Label updates

FDA date:

106 drug labels took effect on Tue, Mar 25; 5 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.

Browse label updates 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.