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May 01, 2024
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FDA approves Ingrezza sprinkle capsules for tardive dyskinesia, Huntington’s chorea

The FDA has approved Ingrezza sprinkle capsules to treat adults with Huntington’s disease chorea or tardive dyskinesia, according to a press release from the manufacturer.

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September 14, 2023
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FDA accepts new drug application for sprinkle form of Ingrezza capsules

The FDA has accepted a new drug application from Neurocrine Biosciences Inc. for its novel granule formulation of oral Ingrezza capsules, for those with tardive dyskinesia or chorea associated with Huntington’s disease.

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September 11, 2023
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Amneal receives FDA approval for Vyvanse generic for ADHD, binge-eating disorder

Amneal Pharmaceuticals has received an abbreviated new drug application from the FDA for its lisdexamfetamine dimesylate capsules to treat ADHD in patients aged 6 years and older and moderate to severe binge-eating disorder in adults.

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June 01, 2023
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FDA approves 20 mg nitisinone capsules for hereditary tyrosinemia

The FDA has approved the 20 mg version of nitisinone used to treat hereditary tyrosinemia, according to a press release.

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May 13, 2022
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FDA approves Sun Pharmaceuticals’ generic mesalamine extended-release capsules for UC

Sun Pharmaceutical Industries received FDA approval of its abbreviated new drug application for mesalamine extended-release capsules indicated for use in ulcerative colitis, according to a press release.

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October 27, 2021
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FMT capsules may improve cognition for certain patients with hepatic encephalopathy

LAS VEGAS — Fecal microbiota transplant capsules may improve cognition in patients with hepatic encephalopathy; however, results may vary by donor and recipient factors, according to a presentation at the ACG Annual Scientific Meeting. “FMT is likely safe with rigorous screening protocol, though some patient subgroups with very advanced cirrhosis and decompensated disease potentially warrant exclusion of this treatment,” Patricia P. Bloom, MD, transplant hepatologist from the University of Michigan, said during the presentation. “It is possible reversing rifaximin (Xifaxan, Salix Pharmaceuticals) resistance is another mechanism by which FMT is effective in this condition.”