Vera Lab gets US FDA nod for drug

City-based Matrix Laboratories Ltd on Friday announced that Vera Laboratories "� a company that is being merged with Matrix "� had received the US FDA approval for Trazodone, an anti-depressant drug.

Trazodone, an off-patent product sold under Desyrel brand name as well as a generic drug in the US, has annual sales of about $75 million.

Vera's customer is one of the major generic players for Trazodone in the US market.

Trazodone is commonly prescribed for the treatment of depression and is also used to reduce the symptoms of agoraphobia, drug induced insomnia, essential tremor, repetitive screaming and some pain related syndromes.

Since Vera's customer has already received US FDA approval for its abbreviated new drug application, the Trazodone active pharmaceutical ingredient shipments will commence shortly from Vera's facility near Vizag, a press release said.

It is expected that the US FDA approval will help Matrix improve the capacity utilisation of the Vera facility and by the end of the year Matrix hopes to fully utilise Vera's capacity in a year as Drug Master Files (DMFs) for some more products would be filed soon.

Matrix has filed 15 DMFs with the US FDA as of March 2004, and it plans to file at least 18 DMFs during the current fiscal.

The press release also said that the legal process to merge Vera with Matrix was on and a court convened extraordinary general meeting of Vera and Matrix Laboratories for the approval is scheduled to be held on July 21 and July 23 respectively.