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news.FDA has accepted the Intellipharmaceutics International's filing of abbreviated new drug application (ANDA) for a generic version of the antidepressant Effexor XR (venlafaxine hydrochloride).
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Intellipharmaceutics’ application will now proceed to full review by the FDA. Intellipharmaceutics aims to develop its pipeline products to an advanced stage, and will now seek a commercialization and distribution partner for this product in the US.
Intellipharmaceutics’ venlafaxine hydrochloride extended release capsules utilize the company’s proprietary controlled release drug delivery technologies. It is one of 15 products that Intellipharmaceutics is developing.
Isa Odidi, CEO and co-chief scientific officer of Intellipharmaceutics, said: “We are very pleased with the further credibility that the acceptance of the filing of this drug application provides our company and our scientific team. This product was entirely developed and filed using our in-house laboratory, manufacturing and regulatory resources. The acceptance of this filing also fulfills one of our key milestones for the year 2010.”