Copaxone 40mg Generic: FDA Exceeds Mylan's Expectations
FDA approves the product well before Mylan's prediction of 2018.
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By conducting a product development or pre-submission meeting, sponsors can receive a mid-review cycle meeting for a complex product ANDA.
Company says that while FDA has focused on expediting approval of third and fourth generics, it has not done so for first generics and complex products.
US agency has received 'very few' inquiries about the drugs on the list since its release.