Actualités réglementaires
23 sept. 2026•1 min de lecture
Roche’s ENDEP (Amitriptyline HCl 150mg) ANDA085303 Approved; product now discontinued
The FDA approved Roche’s ANDA085303 for ENDEP, an oral 150 mg amitriptyline hydrochloride tablet. The product is currently listed as discontinued.
Actualités réglementaires
12 sept. 2026•1 min de lecture
FDA Approves NIPRIDE (Sodium Nitroprusside) Injection – NDA 017546
FDA approved Roche's injectable NIPRIDE (sodium nitroprusside 50 mg/vial) under NDA 017546 in 1974; the product is now discontinued after multiple labeling updates.
Actualités réglementaires
6 sept. 2026•1 min de lecture
Roche and Eli Lilly's Elecsys pTau217 Blood Test Receives FDA Approval
Roche and Eli Lilly's Elecsys pTau217 blood test for Alzheimer’s received FDA clearance, measuring phosphorylated tau 217 to aid diagnosis and exclusion.
Actualités réglementaires
25 août 2026•1 min de lecture
FDA Lists ENDEP Amitriptyline Tablet Products (ANDA083639)
FDA’s ANDA083639 lists five ENDEP oral amitriptyline tablets (10‑100 mg) from Roche, all marked discontinued.