U.S. Regulatory News March 2019

reg-news-2019


News of FDA generic drug and regular approvals for humans and animals.

Source: Bloomberg BNA (reports from January 14 and 21, 2019) and the Food and Drug Administration website. Compiled by Linda C. Brown, managing editor.

HUMAN |ANIMAL

 

HUMAN
Company Trade Name Generic Name Action

Amneal Pharmaceuticals Co. 

 lurasidone hydrochloride tablets

FDA approved generic version of Latuda by Sunovion for the treatment of depressive episode associated with bipolar I disorder (bipolar depression) in adults.
InvaGen Pharmaceuticals Inc., Lupin Ltd., Accord Healthcare Inc., Torrent Pharmaceuticals Ltd., Sun Pharama Global FZE lurasidone hydrochloride tablets

FDA approved generic version of Latuda by Sunovion for the treatment of schizophrenia and depressive episodes associated with bipolar I disorder (bipolar depression) in adults.

Teva Pharmaceuticals USA Inc.

 vigabatrin tablets

FDA approved generic version of Sabril by Lundbeck for the treatment of refractory complex partial seizures in patients 10 years of age and older who have responded inadequately to several alternative treatments.

 

ANIMAL
Company Trade Name Generic Name Action
Boehringer Ingelheim Vetmedica, Inc. Pexion imepitoin FDA approved Pexion for treatment of noise aversion in dogs.
Ceva Sante Animale MilbeGuard milbemycin oxime FDA approved MilbeGuard for use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control of adult Toxocara canis and Toxascaris leonina (roundworms) and Trichuris vulpis (whipworm) infections in dogs and in puppies four weeks of age or greater and two pounds body weight or greater; and for use in the prevention of heartworm disease caused by Dirofilaria immitis, and the removal of adult Ancylostoma tubaeforme (hookworm) and Toxocara cati (roundworm) in cats and kittens six weeks of age or greater and 1.5 lbs. body weight or greater.

Table of Contents
March 2019

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