Regulatory Updates
Aug 26, 2026•1 min read
FDA Approves ANDA078101 for Teva’s Levetiracetam Oral Tablets
The FDA has approved labeling submissions for Teva Pharm’s discontinued levetiracetam tablets (250 mg, 500 mg, 750 mg, 1 g) under ANDA078101.
Regulatory Updates
Aug 23, 2026•1 min read
Teva UK reports labeling error on Ponlimsi (Denosumab) 60mg carton
Teva UK Limited has identified a labeling mistake on the Ponlimsi (Denosumab) 60 mg pre‑filled syringe carton, which incorrectly states “For application to the skin” despite the product being licensed for subcutaneous injection.
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