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FDA Watch: Approvals for Novartis, Amgen; designations for Eli Lilly, Merck KGaA

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.

SNL Image
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.