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WeeZuhl

01/02/18 1:06 PM

#280536 RE: WeeZuhl #280375

I'm sure there's a good reason why a company seeks and gets approval for an ANDA they already own. I can't wait to hear what this is about.







The Phendimetrazine Tartrate approval is from an Elite ANDA filed approximately six years ago. Since the filing, Elite obtained a second, approved Phendimetrazine Tartrate ANDA through Mikah Pharma. Elite has been selling this generic product for more than five years. Elite is considering strategic options, including divestiture, for this newly approved ANDA.

“An ANDA approval for Phendimetrazine Tartrate at the end of 2017 was a welcome occurrence,” commented Nasrat Hakim, President and CEO of Elite. “We look forward to additional approvals in 2018 from more recent filings."