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Source: TIMES NEWS NETWORK - FRIDAY, JULY 09, 2004 07:28:43 PM
HYDERABAD: Vera Laboratories, which is in the process of getting merged with the city-based Matrix Laboratories Ltd, has received the US FDA approval for Trazodone, an anti-depressant drug.

Trazodone, an off-patent product sold under Desyrel brand name and in the generic form in the US, has an annual sales value of about $75 million, Matrix said in a statement.

Vera's customer is one of the major generic players for Trazadone in the US market. Though the product is commonly prescribed for the treatment of depression, it is also used to reduce the symptoms of agoraphobia, drug induced insomnia, essential tremor, repetitive screaming and some pain syndromes, the company said.

Since the company's customer has already received the US FDA approval for the abbreviated new drug application, the Trazadone active pharmaceutical ingredient shipments from Vera's facility will commence immediately, the company said.

The FDA approval for Trazadone will enable Matrix to improve the capacity utilisation of Vera's facility located near Visakhapatnam. "Matrix hopes to fully utilise the capacity available with Vera within a year, as drug master files (DMFs) for some more products are being filed soon," it said.

While Matrix has filed 15 DMFs with the FDA as of March 2004, it plans to file atleast 18 DMFs during the current fiscal.

Meanwhile, Matrix has initiated legal process to merge Vera Laboratories. The court-convened extraordinary general meetings of Vera and Matrix for the approval would be held on July 21 and 22, 2004, the company said.

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