SPARC or Sun Pharma Advanced Research Company hit a new 52-week high today at Rs.444.90 and the flagship, Sun Pharma also hit a high at Rs.1004.30. Both stocks continue to remain very much in the green, closer to the high levels.

The stocks have spurted up after SPARC announced that the US FDA has approved its new drug application (NDA) for Elepsia XR, to be manufactured by Sun Pharma at its Halol plant in Gujarat. This is good news for the company when two months ago, the FDA did not approve its anti-glaucoma eye-drop for sale in the US market.

Interestingly, the very same dug which has got the approval now was rejected in 2013 and the FDA specified that the clinical data submitted by SPARC establishes bioequivalence in the fasted state.  It also raised queries on the pharmacokinetic data in the fed state. Clearly, SPARC has worked on these observations and then got the well deserved approval.