MYX mayne pharma group limited

Ann: Mayne Pharma launches clozapine tablets in the US, page-3

  1. 6,633 Posts.
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    There are 5 other companies making it in 100mg form, but annual sales of $125m, and thats still ok.

    Im not sure i understand how approval works, but FDA says 25mg and 100mg was approved on Sep 17, 2015, 50 and 200 on Aug 22, 2017.

    So why is the announcement now, did they sit on the approval since then without manufacturing it ?
    (EDIT: oh it was probably approved under TEVA)

    https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=203807
    Last edited by bug1: 09/11/17
 
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