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FDA Watch: Approval for Novartis; priority review for Pfizer, Astellas

Approvals and designations made by the U.S. Food and Drug Administration for the week ended March 23.


* Novartis AG's Tasigna, for children one year of age or older with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase, or Ph+ CML-CP. The drug is already approved to treat adults and children with Ph+ CML-CP resistant or intolerant to prior tyrosine kinase inhibitor therapy and prior therapy.

* Orthofix International NV's G-Beam fusion beaming system, for Charcot foot. The company received 510(k) clearance.

* Sun Pharmaceutical Industries Ltd.'s Ilumya, for moderate to severe plaque psoriasis.

* Seattle Genetics Inc.'s Adcetris-chemotherapy combination, for adults with previously untreated stage 3 or 4 classical Hodgkin lymphoma. The drug is already approved to treat three other types of lymphoma as well as certain patients with mycosis fungoides. Seattle Genetics is developing Adcetris with Takeda Pharmaceutical Co. Ltd.

* Restoration Robotics Inc.'s Artas hair transplantation system, for pattern baldness. The company received 510(k) clearance.

SNL Image
FDA headquarters in Silver Spring, Md.
Source: Associated Press

Priority review

* Pfizer Inc. and Astellas Pharma Inc.'s Xtandi, for patients with castration-resistant prostate cancer that has not spread to other parts of the body. The drug is already approved to treat certain patients with castration-resistant prostate cancer.

Fast track

* Fennec Pharmaceuticals Inc.'s Pedmark, to prevent ototoxicity, or ear damage, as a side-effect of cisplatin chemotherapy in children with standard-risk hepatoblastoma.

Other designations: orphan drug

* Trillium Therapeutics Inc.'s TTI-621, for cutaneous T-cell lymphoma.

* Cellectar Biosciences Inc.'s CLR 131, for neuroblastoma. The company is evaluating the drug in other indications, including multiple myeloma.