Food and Drug Administration (FDA) has accepted for filing by Intellipharmaceutics International Inc, for abbreviated new drug application (ANDA) for a generic version of the antidepressant Effexor XR (venlafaxine hydrochloride).
The company's application will now proceed to full review by the US FDA. Intellipharmaceutics endeavours to develop its pipeline products to an advanced stage, and will now seek a commercialization and distribution partner for this product in the United States. No assurance can be given as to when or if the US FDA will approve the Company's application for the product.
"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," stated Dr Isa Odidi, CEO and co-chief scientific officer of Intellipharmaceutics. "This product was entirely developed and filed using our in-house laboratory, manufacturing and regulatory resources. The acceptance of this filing also fulfils one of our key milestones for the year 2010."
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.
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of controlled and targeted novel oral solid drugs.