Pharmaceutical Business review

TWi obtains FDA tentative approval for Guanfacine Hydrochloride ANDA

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."