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FDA Watch: Approvals for Roche, Merck & Co., Medtronic


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FDA Watch: Approvals for Roche, Merck & Co., Medtronic

Approvals and designations made by the U.S. Food and Drug Administration for the week ended June 15.


* Roche Holding AG's Avastin-chemotherapy combination, for women with advanced ovarian cancer who had undergone surgery. Avastin is now approved in the U.S. for 10 uses across six types of cancer.

* Merck & Co. Inc.'s Keytruda, for primary mediastinal large B-cell lymphoma, as well as cervical cancer. Keytruda is already approved to treat multiple types of cancers.

* Medtronic PLC's IN.PACT Admiral balloons, to treat 200-millimeter and 250-millimeter lesions in patients with peripheral artery disease. The device's 360 millimeter version was approved in April.

* Mylan NV and Dr. Reddy's Laboratories Ltd.'s generic versions of Suboxone film, Indivior PLC's treatment for opioid use disorder.

* LivaNova PLC's Memo 4D, a semi-rigid mitral annuloplasty ring to treat mitral regurgitation.

* Cutera Inc.'s truSculpt 3D, a nonsurgical body sculpting system, for lipolysis. The device is already approved to reduce fat without surgery.

* Wright Medical Group NV's Augment injectable bone graft, for foot and ankle procedures. Wright Medical expects to launch the product within the next four to six weeks.

* Agilent Technologies Inc.'s Dako PD-L1 IHC 22C3 pharmDx, an in vitro diagnostic test to identify patients with non-small cell lung cancer or stomach cancer who would benefit from anti-PD-1 immunotherapy.

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

Complete response letters

* ScPharmaceuticals Inc.'s Furoscix, which was meant to treat edema in people with heart failure. The FDA said ScPharmaceuticals needs to consider device modifications and conduct additional research.

Priority review

* Merck & Co.'s Gardasil 9, a human papillomavirus vaccine against certain cancers and diseases in men and women ages 27 to 45. The application's target action date is Oct. 6.

Fast track

* Regenxbio Inc.'s RGX-111, for mucopolysaccharidosis type I.

* Nordic Nanovector ASA's Betalutin, for certain patients with follicular lymphoma.

Other designations

* Regenerative medicine advanced therapy, for Nightstar Therapeutics Ltd.'s NSR-REP1, to treat choroideremia.

* Rare pediatric disease, for Albireo Pharma Inc.'s A4250, to treat progressive familial intrahepatic cholestasis. The FDA previously granted A4250 orphan drug status.