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FDA approves Breckenridge’s generic of Pfizer’s anti-epilepsy drug

pharmafile | March 18, 2016 | News story | Research and Development, Sales and Marketing FDA, Neurontin, Pfizer, anti-epilepsy, approval, breckenridge, gabapentin, tris pharma 

Breckenridge Pharmaceutical Inc. has announced that their generic of Pfizer’s anti-epilepsy drug Neurontin (gabapentin) has been approved by the US Food and Drug Administration.

Developed by Tris Pharma, Breckenridge will market and distribute the oral solution, which is AA rated to Neurontin. According to IMS Health sales data, annual generic sales of gabapentin oral solution totals $9.3 million.

The treatment is indicated as an adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalisation, in adults and paediatric patients 3 years and older with epilepsy.

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Neurontin has a troubled history, with Pfizer criticised in the past for its marketing of the drug. In 2004, they agreed a settlement of $430 million after allegations it had promoted the drug as efficacious for conditions such as ADHD, mental illnesses and migraine headaches.

In 2014, they also agreed to pay $190 million to end a suit which claimed it had violated US antitrust law in delaying generic versions of Neurontin.

Breckenridge in the final stages of planning product launch plans and the first shipment will occur shortly.

Sean Murray

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