MHRAsafety guidance54% confidence
UPDATE: Class 4 Medicines Defect Notification: Relonchem Limited, Gabapentin Relonchem 50mg/ml Oral Solution, EL(26)A/31
Source: MHRA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Teva.
Regulatory Analysis
Relonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint.
Supporting Context
- Therapeutic area
- Neurology · Anticonvulsant
- Sub-indication
- General
Related signal: Teva's Gabapentin ANDA205807 Receives AP Status from FDA