Approvals and designations made by the U.S. Food and Drug Administration for the week ended June 8.
Approvals
* AbbVie Inc. and Roche Holding AG's Venclexta-Rituxan combination, for certain patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Venclexta is already approved to treat CLL or SLL.
* Roche's Rituxan, for adults with moderate to severe pemphigus vulgaris. The FDA previously granted Rituxan priority review, breakthrough therapy and orphan drug designations.
* Eli Lilly and Co. and Merck & Co. Inc.'s Alimta-Keytruda combination, for certain patients with non-small cell lung cancer. Alimta is already approved to treat different types of NSCLC.
* EDAP TMS SA's Focal One device, to view 3D images of the prostate and direct ultrasound waves to remove the targeted area. The company received 510(k) clearance.
* K2M Group Holdings Inc.'s Ozark cervical plate systems, to facilitate spinal balance in patients with degenerative disease, deformity, tumor or trauma.
* Insulet Corp.'s Omnipod Dash, an insulin management system. The company received 510(k) clearance, and plans to launch the product in early 2019.
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| FDA headquarters in Silver Spring, Md. |
| Source: Associated Press |
Complete response letters
* Amgen Inc.'s ABP 980, a biosimilar version of Roche's breast cancer drug Herceptin. The company said it does not expect the rejection to impact its U.S. launch plan.
Priority review
* Roche's Hemlibra, for certain adults and children with hemophilia A. The application's target action date is Oct. 4.
Other designations
* Orphan drug, for Ironwood Pharmaceuticals Inc.'s olinciguat, to treat sickle cell disease.
* Orphan drug, for Ascendis Pharma A/S's TransCon PTH, to treat hypoparathyroidism.
* Rare pediatric disease, for Cellectar Biosciences Inc.'s CLR 131, to treat rhabdomyosarcoma. The FDA previously granted CLR 131 orphan drug status, as well as rare pediatric disease designation for neuroblastoma.
* Orphan drug, for Alnylam Pharmaceuticals Inc.'s ALN-TTRsc02, to treat transthyretin-mediated amyloidosis.

