Approvals and designations made by the U.S. Food and Drug Administration for the week ended Sept. 6.
Approvals
* Endo International PLC's first generic version of Swedish Orphan Biovitrum AB (publ)'s medicine Orfadin for hereditary tyrosinemia type 1.
* Boehringer Ingelheim Corp.'s Ofev as the first treatment for systemic sclerosis.
* Oventus Medical Ltd.'s oral device O2Vent Optima for obstructive sleep apnea.
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Fast track
* Forty Seven Inc.'s magrolimab for myelodysplastic syndrome and acute myeloid leukemia.
Breakthrough therapy
* Novartis AG's oral drug capmatinib as initial treatment for metastatic non-small cell lung cancer with the MET exon-14 skipping genetic mutation.
* Johnson & Johnson's investigational vaccine for preventing respiratory syncytial virus.
Other designations
* Orphan drug, for Puma Biotechnology Inc.'s Nerlynx for breast cancer that has spread to the brain.
* Orphan drug, for BioXcel Therapeutics Inc.'s BXCL701 for acute myeloid leukemia.
* Orphan drug, for GeneTx Biotherapeutics LLC and Ultragenyx Pharmaceutical Inc.'s GTX-102 for Angelman syndrome.
* Orphan drug, for Ra Pharmaceuticals Inc.'s zilucoplan for myasthenia gravis.
* Rare pediatric disease, for GeneTx Biotherapeutics and Ultragenyx Pharmaceutical's GTX-102 for Angelman syndrome.
* Regenerative medicine advanced therapy, for Magenta Therapeutics Inc.'s experimental one-time cell therapy MGTA-456 for Hurler syndrome, cerebral adrenoleukodystrophy, metachromatic leukodystrophy or globoid cell leukodystrophy.

FDA headquarters in Silver Spring, Md.