Taiwan-based specialty pharmaceutical company TWi Pharmaceuticals has obtained FDA tentative approval for its abbreviated new drug application (ANDA) for Guanfacine Hydrochloride Extended Release tablets 1mg, 2mg, 3mg and 4mg.
The central alpha2A-adrenergic receptor agonist is indicated as monotherapy and adjunctive therapy to stimulant medications for Attention De?cit Hyperactivity Disorder (ADHD).
TWi Pharmaceuticals president Dr. Calvin Chen said, "TWi had already reached a settlement agreement with the branded product manufacturer and intends to begin shipping its Guanfacine Hydrochloride product upon receiving the final approval from U.S. FDA."
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/twi-obtains-fda-tentative-approval-for-guanfacine-hydrochloride-anda-150513
