Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling

… Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# … 5 mg UD Blister Cards may potentially be mislabeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blisters … such as operating machinery or driving a motor vehicle. Amantadine has a precaution in its prescribing indication …

FDA Investigates Animal Illnesses Linked to Jerky Pet Treats

… sulfanomides, quinolones, and tetracyclines) Antivirals (amantadine, rimantadine, oseltamivir, and others) Mold and … treat samples and identified 27 that tested positive for amantadine. FDA did not request a recall of these treats … and/or antibiotic residues. FDA does not believe that amantadine contributed to the illnesses because the known …

January - March 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

… FDA is evaluating the need for regulatory action. Gocovri (amantadine) Osmolex ER (amantadine)   Corneal oedema FDA is evaluating the need for …

Influenza (Flu) Antiviral Drugs and Related Information

… as generic) Xofluza (baloxavir marboxil) Two older drugs, amantadine (generic) and rimantadine (Flumadine and generic) … to these drugs. CDC has not recommended the use of amantadine and rimantadine for recently circulating influenza …

Olgica Ceric

… Determination and confirmation of the antiviral drug amantadine and its analogues in chicken jerky pet treats. …

First Generic Drug Approvals

… opioid dosage escalation for palliative care 54 214897 Amantadine Extended-Release Capsules, 68.5 mg Zydus Worldwide DMCC Gocovri (Amantadine) Extended-Release Capsules 8/26/2024 For the …

Bulk Drug Substances Currently Under Review

… Aluminum hydroxide dog, cat FDA-2018-N-4626-0048 Amantadine dog, horse FDA-2018-N-4626-0136 Aminopentamide …

Drug-Induced Liver Injury Severity and Toxicity (DILIst) Dataset

… 1 Oral 236 alprazolam 1 Oral 237 altretamine 0 Oral 238 amantadine 0 Oral 239 4-aminosalicylic acid 1 Oral 240 …

Drug Induced Liver Injury Rank (DILIrank) Dataset

… Warnings and precautions Ambiguous DILI-concern 2 LT00503 amantadine 3 Warnings and precautions Ambiguous DILI-concern …

September 2023: Additions and Deletions to the Drug Product List

September 2023: Additions and Deletions to the Drug Product List

September 2021 Additions and Deletions to the Drug Product List (Orange Book)

June 2017: Additions and Deletions to the Drug Product List

May 2017: Additions and Deletions to the Drug Product List (PDF)

365_210854 baloxavir CDTL DD clinical prea

August 2024: Additions and Deletions to the Drug Product List

December 2022: Additions and Deletions to the Drug Product List

January 2017: Additions and Deletions to the Drug Product List

February 2020 Additions and Deletions to the Drug Product List (Orange Book)

September 2018: Additions and Deletions to the Drug Product List

February 2020: Additions and Deletions to the Drug Product List

January 2021: Additions and Deletions to the Drug Product List

September 2019: Additions and Deletions to the Drug Product List (PDF - 205KB)

September 2020 Additions and Deletions to the Drug Product List (Orange Book)

July 2019: Additions and Deletions to the Drug Product List