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Showing posts from March, 2021

API and IP Newsletter

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  Contents FDA approvals in February 2021.  General information.  Novartis' Sandoz, with Aubagio generic in its sights, sues FDA to launch copycat first   By April 28 decide on 2 TB drugs, Bombay HC tells Centre .  Intellectual Property.  FDA approvals in February 2021   Sr. Brand API FDA-approved use on approval date* 1 Pepaxto melphalan flufenamide 2/26/2021 For the treatment of certain patients with relapsed or refractory multiple myeloma 2 Nulibry fosdenopterin 2/26/2021 To treat patients with the rare genetic disease molybdenum cofactor deficiency Type A Press Release 3 Amondys 45 casimersen 2/25/2021 For the treatment of Duchenne muscular dystrophy Press Release 4 Cosela trilacicilib 02/12/21 To mitigate chemotherapy-induced myelosuppression in adult patients with small cell lung cancer Press Release 5 Evkeeza evinacumab-dgnb 02/11/21 For the treatment of homozygous familial hypercholesterolemia 6 Ukoniq umbralisib 02/05/21 For the treatment of certain patients with marginal