Apopharma`s Generic Apremilast Receives Approval in the U.S.
On March 29, 2016, the United States Food and Drug Administration (FDA) updated its so-called Paragraph IV Certification List with two (2) new drugs for which the FDA has received abbreviated new drug applications (ANDAs) containing a patent challenge. The targeted new drug products are: (i) ApoPharma Inc.’s Ferriprox (Deferiprone) Tablets, 500mg; and (ii) Oak Pharmaceuticals, Inc.'s (a subsidiary of Akorn Pharmaceuticals) Zioptan (Tafluprost) Ophthalmic Solution, 0.0015%. The dates of submission of the respective ANDAs containing a patent challenge for these two new drug products are January 29, 2016 and February 10, 2016.
ApoPharma Announces Health Canada Approval of Ferriprox (deferiprone)
Apotex Announces FDA Has Accepted For Filing its Biosimilar Application for Filgrastim (Grastofil™)