FDA daily for Thursday, September 17, 2026
In this issue: 31 shortage updates and 10 approvals. 1 item touches categories MedGrid carries, and it comes 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.
- Sterile Water Irrigant
Otsuka ICU Medical LLC · Unavailable · Reason: Discontinuation of the manufacture of the drug
Drug shortages
FDA date:FDA updated 31 shortage entries on Wed, Sep 16: 2 new, 2 to be discontinued, 27 status updates.
- Sterile Water Irrigant
Otsuka ICU Medical LLC · Unavailable · Reason: Discontinuation of the manufacture of the drug
- Mesalamine Capsule, Extended Release
Takeda Pharmaceuticals USA Inc.
- Melphalan Hydrochloride Injection
Fresenius Kabi USA, LLC
- Amino Acid Injection
Otsuka ICU Medical LLC · Available
- Clonazepam Tablet
Cheplapharm Arzneimittel GmbH · Available
- Conivaptan Hydrochloride Injection
Cumberland Pharmaceuticals Inc. · Unavailable · Reason: Delay in shipping of the drug
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet
Elite Laboratories, Inc. · Available
- Methylphenidate Hydrochloride Tablet, Extended Release
Vertical Pharmaceuticals, LLC · Available
- Lidocaine Hydrochloride Injection
Amphastar Pharmaceuticals, Inc. · Limited Availability · Reason: Demand increase for the drug
- Dextrose Monohydrate 5% Injection
Otsuka ICU Medical LLC · Available
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet
Sunrise Pharmaceutical, Inc. · Available
- Bumetanide Injection
MSN Laboratories Private Limited · Available
- Lisdexamfetamine Dimesylate Capsule
Apotex Corp. · Available
- Lisdexamfetamine Dimesylate Tablet, Chewable
Novadoz Pharmaceuticals LLC · Available
- Lisdexamfetamine Dimesylate Capsule
Elite Laboratories, Inc. · Limited Availability · Reason: Shortage of an active ingredient
Drug and biologic approvals
FDA date:On Thu, Sep 10 FDA approved 2 new applications (0 brand or biologic, 2 generic) and 8 supplements to existing ones.
- ISOTRETINOIN
AUROBINDO PHARMA LTD · ISOTRETINOIN
- SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
RUBICON RESEARCH · HYDROCHLOROTHIAZIDE, SPIRONOLACTONE
FDA did not answer for Drug recalls, Clearances, Device recalls, Food and supplement recalls, Labels while this issue was written; those sections will fill in on a later visit.
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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