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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
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.