FDA Approves Pharmadax Generic Version of Seroquel XR

Pharmadax announced that U.S. FDA has approved the generic equivalent of Seroquel XR (quetiapine fumarate) ER tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg, launched by Pharmadex in collaboration with TruPharma.

Pharmadax Chairman, Yipin Huang said that they are very excited to receive approval of their first controlled-release product, and second overall approval by the US FDA. Launching this product in the US market is a major milestone for Pharmadax.  Leveraging on their unique business model and technology platform, they look forward to providing more affordable and high quality complex dosage forms to the American public.

Seroquel XR is a tablet for the treatment of schizophrenia; acute depressive episodes in bipolar disorder; acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; and adjunctive therapy to antidepressants for patients with major depressive disorder (MDD).