![]() ![]() ![]() 8 Gabapentin lost its product exclusivity on May 24, 2005, and subsequently Pfizer introduced pregabalin with an FDA-approved indication for DPN (See Table 1). 7 Some of these off-label uses include: panic disorder, migraine prophylaxis, social phobia, mania, bipolar disorder, and alcohol withdrawal. 6 However, during the past 12 years, off-label use has accounted for the largest percentage of gabapentin prescriptions. Gabapentin was approved by the FDA on December 30, 1993, for adjunctive therapy in the treatment of partial seizures in adults and pediatric patients (3-12 years of age) and also approved in 2002 for pain management of PHN in adults.
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