Zydus Cadila gets US FDA nod to market drug for treatment of epilepsy

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the Indian Bourses on Tuesday, Cadila Healthcare Ltd (Dr Pankaj Patel owned Zydus Cadila group) said of having availed regulatory approval from US Food and Drugs Administration (USFDA) to market drug to treat epilepsy.

Zydus Cadila has received the final approval from the USFDA to market Clobazam Tablets, (US RLD — ONFI® Tablet), 10 mg and 20 mg, the statement read.

Clobazam is used in combination with other medications to treat seizures caused by a paediatric epilepsy syndrome (termed as Lennox-Gastaut syndrome) that also caused developmental and behavioural problem.

It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.

The group now has 224 approvals and has so far filed over 330 ANDAs (Abbreviated New Drug Application) since the commencement of the filing process in FY 2003-04.

However, the announcement made by the company hit the exchanges, while the shares of the company continued trading flat, where inverstors & traders sentiment did not make any impact either on the share price or the trade volumes, as the trading session for the day ended on the Indian Bourses on Tuesday, Cadila Healthcare shares ended on a slight negativity.