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JamesF1

10/30/23 12:35 PM

#390229 RE: mrwrn2010 #390228

My GUESS is it’s an FDA delay. I know they have a goal of 10 months for 90 % of ANDA’s but it’s only been few days since the 10 month mark passed. I also would GUESS a small market product like an extended release dopamine agonist would not be a priority for the FDA.