brisbane presentation, page-12

TDA;
They had the packaging, cartons and syringes on display at the AGM - looks very professional even though they were not the final printed version. As I understand things, all the aspects of the ANDA are reviewed in parrallel - chemistry, labelling and packaging, sterility, stabillity etc. The format is Q&A where each branch asks questions and interacts with the sponsor (Reddy's). When each branch is satisfied with the submission and responses the whole package goes to committee for final approval. Packaging and labelling is very important because the FDA will want the box colours and syringe colours to reflect the innovators product so that mistakes aren't made in dosing - it would be a very bad look to have the innovators 2.5 mg in ble and the 10 mg in red and the generic colouring to be opposite. Also the "labelling" goes to what the generic marketer can claim as indications (uses) for the product. Therefore they need to tread carefully around ACS and other "protected" uses.
The suggestion that they are discussing labelling does not mean the other branches are signed off on - but it is encouraging because it means they are actively engaged with the FDA and that the process has not stalled. I am optomistic of a great result here.