FDA daily for Thursday, October 15, 2026
In this issue: 28 shortage updates, 17 approvals, 19 device decisions and 6 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.
- Liraglutide Injection
Hikma Pharmaceuticals USA, Inc. · Available
- Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink
Yty Industry (Manjung) Sdn Bhd · General Hospital
Drug shortages
FDA date:FDA updated 28 shortage entries on Wed, Oct 14: 2 new, 2 to be discontinued, 24 status updates.
- Liraglutide Injection
Hikma Pharmaceuticals USA, Inc. · Available
- Dexmedetomidine Hydrochloride Injection
Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.)
- Everolimus Tablet
Par Health, USA LLC
- Cefotaxime Sodium Powder, for Solution
Hikma Pharmaceuticals USA, Inc. · Unavailable · Reason: Demand increase for the drug
- Morphine Sulfate Injection
Hikma Pharmaceuticals USA, Inc. · Available
- Rocuronium Bromide Injection
Hikma Pharmaceuticals USA, Inc. · Available
- Furosemide Oral Solution
Hikma Pharmaceuticals USA, Inc. · Limited Availability · Reason: Shortage of an inactive ingredient component
- Fentanyl Citrate Injection
Hikma Pharmaceuticals USA, Inc. · Available
- Etomidate Injection
Hikma Pharmaceuticals USA, Inc. · Available
- Lorazepam Injection
Hikma Pharmaceuticals USA, Inc. · Unavailable · Reason: Other
- Hydromorphone Hydrochloride Injection
Hikma Pharmaceuticals USA, Inc. · Available
- Meperidine Hydrochloride Injection
Hikma Pharmaceuticals USA, Inc. · Available
- Lisdexamfetamine Dimesylate Capsule
Hikma Pharmaceuticals USA, Inc. · Limited Availability · Reason: Shortage of an active ingredient
- Remifentanil Hydrochloride Injection
Hikma Pharmaceuticals USA, Inc. · Unavailable · Reason: Demand increase for the drug
- Dexamethasone Sodium Phosphate Injection
Hikma Pharmaceuticals USA, Inc. · Unavailable · Reason: Demand increase for the drug
Drug and biologic approvals
FDA date:On Thu, Oct 8 FDA approved 3 new applications (2 brand or biologic, 1 generic) and 14 supplements to existing ones.
- PITOLISANT HYDROCHLORIDE
ANNORA PHARMA · PITOLISANT HYDROCHLORIDE
- WELTRUZA
TEVA NEUROSCIENCE INC · OLANZAPINE
- BREZTRI AEROSPHERE
ASTRAZENECA AB · BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE
Device clearances and approvals
FDA date:FDA decided 10 510(k)s and 9 PMA decisions on Thu, Oct 1, including 1 original PMA.
- Autus Size-Adjustable Valve
Edwards Lifesciences, LLC · Heart-valve, polymeric · Cardiovascular
- Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink
Yty Industry (Manjung) Sdn Bhd · General Hospital
- Firstar Dental Electric Motor
FDC Technology Industry Co. · Dental
- Dual Stage Venous Cannulae
Sorin Group Italia S.R.L. · Cardiovascular
- Firstar Dental Handpieces
FDC Technology Industry Co. · Dental
- NEXUS® Hip Stem
Microport Orthopedics, Inc. · Orthopedic
- VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)
bioMerieux, Inc. · Microbiology
- SwiftSight-BodyComposition
Airs Medical, Inc. · Radiology
- Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
Shenzhen Brav Electronic Technologies Co., Ltd. · Cardiovascular
- Intra-Operative Positioning System (IOPS) and IOPS Visionary System
Centerline Biomedical · Cardiovascular
- NOVIX Pedicle Screw System
Tdm Co., Ltd. · Orthopedic
Label updates
FDA date:6 drug labels took effect on Thu, Oct 1.
Browse label updates in FDA data →FDA did not answer for Food and supplement recalls, Drug recalls, Device recalls 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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