Lupin receives US FDA tentative nod for escitalopram oxalate tablets (PharmaBiz)
Lupin Ltd announced that its subsidiary in the US, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for the abbreviated new drug application (ANDA) for escitaloprarn oxalate tablets 10 mg and 20 mg from the US Food and Drug Administration (US FDA).

FDA Allows Halcygen's IND Application, Pivotal US-Based Clinical Trials To Proceed - SUBATM-Itraconazole Is An ... (Medical News Today)
HalcyGen Pharmaceuticals Limited (ASX:HGN) has received approval from the US Food and Drug Administration (FDA) to begin pivotal pharmacokinetic* (PK) studies in the United States. These studies are the precursor to SUBATM-Itraconazole product registration. The allowance to proceed comes 30 days after HalcyGen submitted its Investigational New Drug (IND) application (announced 14 May 2008).