Approvals and designations made by the U.S. Food and Drug Administration for the week ended Dec. 14.
Approvals
* Novartis AG and Pear Therapeutics Inc.'s prescription digital therapeutic reSET-O, a 12-week add-on therapy for adults on buprenorphine with opioid use disorder.
* Amgen Inc.'s Nplate, for certain children with immune thrombocytopenia. Nplate is already approved for adults with chronic immune thrombocytopenia.
* Celltrion Healthcare Co. Ltd.'s Herzuma, a biosimilar version of Roche Holding AG's breast cancer drug Herceptin. Teva Pharmaceutical Industries Ltd. has exclusive rights to commercialize Herzuma in the U.S. and Canada.
* Supernus Pharmaceuticals Inc.'s Oxtellar XR, as a stand-alone therapy for partial-onset seizures in patients ages six to 17. Oxtellar XR is already approved as an add-on therapy for partial-onset seizures in patients ages six to 17.
* Mayne Pharma Group Ltd.'s fungal infection drug Tolsura, for blastomycosis, histoplasmosis and aspergillosis. The company plans to launch Tolsura in January 2019.
* Kuros Biosciences AG's MagnetOS Putty, as a stand-alone bone graft in the extremities and in the pelvis. MagnetOs Putty is already approved as an autograft extender in the posterolateral spine.
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| FDA headquarters in Silver Spring, Md. |
| Source: Associated Press |
Complete response letters
* Mallinckrodt Public Ltd. Co.'s opioid painkiller Roxicodone. The FDA provided guidance on areas of further evaluation necessary to resubmit the application.
Fast track
* Eli Lilly and Co. and Incyte Corp.'s Olumiant, for lupus. Olumiant is already approved for certain adults with moderately to severely active rheumatoid arthritis.
Other designations
* Orphan drug, for Merck KGaA's M7824, for biliary tract cancer.