Bangalore, Nov 28, 2008: India’s Sun Pharmaceutical will have to submit a new ANDA for the approval of its generic venlafaxine extended release tablets.

 

In the petition granted by the USFDA, Abbreviated New Drug Application (ANDA) for tablets citing Wyeth’s ‘Effexor XR’ capsules as the reference will not be accepted.

 

The company had previously filed an ANDA for a bio-equivalent of ‘Effexor XR’ capsules. The FDA has concluded that an ANDA for venlafaxine extended release tablets should reference US-based company Osmotica’s product and not Wyeth’s.

 

Such amendments to a pending ANDA are not permitted as per FDA and thus the company will have to resubmit the ANDA for venlafaxine extended release tablets.