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Horizant, gabapentin enacarbil, not yet on the market
English articles
Research & Development
Horizant, gabapentin enacarbil, not yet on the market
| Horizant, gabapentin enacarbil, not yet on the market |
|
In February 2010 gabapentin enacarbil for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) was not receiving approval by the FDA due to concerns regarding findings of pancreatic acinar cell tumors in rats. Horizant, is a prodrug of Pfizer’s gabapentin. Horizant’s approval was already delayed, because in November 2009, the FDA had pushed back the approval date for Horizant by 90 days due to questions related to the risk evaluation. FDA wanted top receive a risk management plan. Horizant is Glaxo's lead pipeline candidate. Glaxo’s products on the market are facing patent challenges and the company’s pipeline needs to deliver this new drug for cmpensation purposes.. March 2010, Jan M. Keppel Hesselink, MD |
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