Register for Phenytoin Oral Suspension receives FDA approval for treatment of epilepsy
EpilepsyApril 8, 2004
2004 APR 8 - (NewsRx.com & NewsRx.net) -- Taro Pharmaceutical Industries Ltd. (TARO) reported that its U.S. affiliate has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Phenytoin Oral Suspension USP, 125 mg/5 mL (phenytoin oral suspension).
Taro's phenytoin oral suspension is bioequivalent to Parke-Davis' (a division of Warner Lambert) Dilantin-125. Phenytoin oral suspension is an antiepileptic prescription product used in controlling grand mal and temporal lobe seizures and is approved for pediatric use.
According to industry sources, U.S. sales of phenytoin oral suspension products were approximately $23 million in 2003.
"Phenytoin oral suspension is an important product for treating epilepsy in children, an area in which Taro provides several products," said Barrie Levitt, MD, chairman of the company.
In the U.S., Taro markets carbamazepine chewable tablets and oral suspension, used primarily in pediatrics. Like phenytoin oral suspension, these prescription anticonvulsant products are indicated for the control of seizure disorders.
Taro is a multinational, science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing, and marketing of healthcare products. This article was prepared by Women's Health Weekly editors from staff and other reports. Copyright 2004, Women's Health Weekly via NewsRx.com & NewsRx.net.
©Copyright 2004, Women's Health Weekly via NewsRx.com & NewsRx.net
