pregabalin
Drug Details
- Generic Name
- pregabalin
- Brand Names
- pregabalin, PREGABALIN
- Application Number
- ANDA208113
- Sponsor
- Indoco Remedies Limited
- NDC Codes
- 27
- Dosage Forms
- CAPSULE, POWDER
- Routes
- ORAL
- Active Ingredients
- PREGABALIN
Indications and Usage
1 INDICATIONS AND USAGE Pregabalin capsules are indicated for: • Management of neuropathic pain associated with diabetic peripheral neuropathy • Management of postherpetic neuralgia • Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information. Pregabalin capsules are indicated for: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1 ) • Postherpetic neuralgia (PHN) (1) • Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older ( 1) • Fibromyalgia ( 1) • Neuropathic pain associated with spinal cord injury (1 )