Approvals and designations made by the U.S. Food and Drug Administration for the week ended Dec. 15.
* Pfizer Inc.'s Xeljanz, for certain adult patients with active psoriatic arthritis. Xeljanz is already approved to treat adult patients with moderate to severe active rheumatoid arthritis.
* Pfizer's biosimilar Ixifi, for rheumatoid arthritis, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The drug is a biosimilar version of Johnson & Johnson's Remicade and was approved for all eligible indications of the reference product.
* Sanofi's Admelog, for adults with type 2 diabetes as well as adults and children with type 1 diabetes. Admelog, or insulin lispro injection, is similar to Eli Lilly and Co.'s Humalog, which is approved in the U.S.
* GlaxoSmithKline plc's Nucala, for eosinophilic granulomatosis with polyangiitis, formerly known as Churg-Strauss syndrome. Nucala is already approved to treat severe asthma with an eosinophilic phenotype.
* Aclaris Therapeutics Inc.'s Eskata, for raised seborrheic keratoses. The company expects to launch Eskata, a topical solution, in spring 2018.
* Allergan plc's CoolSculpting technology, for improving the appearance of lax tissue in combination with submental fat, or double chin. The approval was granted to Allergan unit Zeltiq Aesthetics Inc.
* Boston Scientific Corp.'s Vercise Deep Brain Stimulation System, for symptoms of Parkinson's disease. The Vercise system first launched in Europe in 2012.
|FDA headquarters in Silver Spring, Md.|
|Source: Associated Press|
* Bristol-Myers Squibb Co.'s Opdivo-Yervoy combination, for intermediate- and poor-risk patients with advanced renal cell carcinoma. The application's target action date is April 16, 2018.
* Merck & Co. Inc.'s Keytruda, for primary mediastinal B-cell lymphoma. The application's target action date is April 3, 2018.
* BioVie Inc.'s BIV201, for refractory ascites due to liver cirrhosis. The patented orphan drug candidate is being evaluated in a phase 2a trial.
* Orphan drug expansion, for Alnylam Pharmaceuticals Inc.'s patisiran, for transthyretin-mediated amyloidosis. The drug's prior designation was for familial amyloidotic polyneuropathy. The company is developing patisiran under a collaboration with Sanofi's Sanofi Genzyme.