Morton Grove Pharmaceuticals, Inc., (MGP), a specialty pharmaceutical company that develops, manufactures and markets a broad line of prescription generic oral liquid, topical and sterile inhalation drugs, reported that the Food & Drug Administration (FDA) cleared for market Phenytoin Oral Suspension, USP, 125 mg/5 mL indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
According to the FDA approval letter dated April 19, 2002, Morton Grove Pharmaceuticals' product was determined to be bioequivalent and, therefore, therapeutically equivalent to Dilantin Oral Suspension, 125 mg/5 mL, of Parke Davis, Division of Warner Lambert Co.
Brian Tambi, chairman, president and CEO, said, "The approval of Phenytoin Oral Suspension raises the prescription pharmaceutical business of MGP to a new and much higher level of drug product offering. MGP's product line now exceeds that of its peers. MGP is now the leading prescription oral liquid drug company. Phenytoin Oral Suspension is the first of a series of major therapeutics we expect to launch over the next several months. We are obviously very excited, and have high expectations for 2002 and 2003 with a number of very important ANDA's that are about to clear FDA reviews. The approval of Phenytoin Oral Suspension is an acknowledgment by the FDA of the current high product quality and CGMP status of MGP. We have been working diligently and patiently to win the confidence of the FDA Chicago District Office in our product quality and regulatory compliance. I am proud we accomplished that goal."