FDA Approved: PREGABALIN — Original Application (Chartwell RX, LLC)

View source ↗

Summary

FDA approves Chartwell RX, LLC's original ANDA for pregabalin, establishing a generic version of the drug.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

• Diabetic Peripheral Neuropathy
• Epilepsy
• Fibromyalgia
• Postherpetic Neuralgia
• Spinal Cord Injury-related Neuropathic Pain

Drugs mentioned

• Pregabalin (Pregabalin)

Snippet

ORIG AP for PREGABALIN (PREGABALIN)