Sun Pharmaceutical Industries Ltd announced that the USFDA has granted Osmotica's Citizen Petition regarding venlafaxine extended release tablets. In this petition, USFDA was requested to refrain from approving any pending Abbreviated New Drug Application (ANDA) for such tablets that cited Wyeth's Effexor XR capsules as the reference drug.
Sun Pharma had previously filed an ANDA with multiple para IV certifications for generic venlafaxine extended release tablets, bio-equivalent to Effexor XR capsules. In a communication sent by USFDA to Osmotica, USFDA has concluded that now an ANDA for venlafaxine extended release tablets should reference Osmotica's product and not Effexor XR.
Additionally, with such amendments to a pending ANDA not being permitted as per USFDA, it has advised the Company to submit a new ANDA if it wishes to pursue approval of an ANDA for venlafaxine extended release tablets. Effexor XR is a registered trademark of Wyeth Pharmaceuticals Inc.
The Sun Pharmaceutical Industries stock was trading at Rs.1087.50, up by Rs.7.30 or 0.68%. The stock hit an intraday high of Rs.1108.90 and low of Rs.1051.
The total traded quantity was 19998 compared to 2 week average of 48823.
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