>Sun pharma , Shoppers stop(BRICS)

Major Setback for Sun as USFDA grants Osmotica's citizen petition
In a major setback to the prospects of Sun Pharma’s launch of generic tablet
version of EffexorXR (Venlafaxine extended release tablets), USFDA has granted
Osmotica's citizen petition. The USFDA has advised Sun to submit a new ANDA
if it wishes to pursue approval of the aforesaid tablets. However, our prima
facie analysis suggests that even if the company re-submits the ANDA application
with Osmotica's venlafaxine extended release tablet being the reference drug, it
would take at least one - one and half years before it gets the approval. On the
flip side, as per the settlement with Wyeth, Teva is expected to launch the
aforesaid generic capsules in July 2010. In this scenario, there may be very little
incentive for Sun Pharma to resubmit the ANDA application.

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