Actualizaciones regulatorias

The FDA has listed the Lactulose oral and rectal solution (product #001) as discontinued under NDA017906, sponsored by Solvay.

The FDA granted a tentative approval for Teva Pharm's ribavirin oral solution (40 mg/mL) under ANDA 077611.

FDA approved ANDA076440 for ANI Pharmaceuticals' risperidone oral solution (1 mg/mL), a prescription atypical antipsychotic, with recent labeling updates in July 2024.

Cypress Pharm Inc.'s ZYFREL oral solution (acetaminophen 325 mg/15 mL and hydrocodone 7.5 mg/15 mL) received FDA approval under ANDA090468, with labeling supplements approved in 2016 and 2017.

FDA has approved ANDA213409 for two oral solution products of nimodipine from ALKEM Labs, with one product receiving prescription status and the other tentative approval.

FDA granted approval for NDA 211281, covering Braintree Labs' PIZENSY oral lactitol solution, with original approval in Feb 2020 and a labeling supplement in Aug 2021.

Scilex Pharmaceuticals' GLOPERBA, an oral colchicine solution (0.6 mg/5 mL), received FDA approval under NDA 210942, with supplemental updates in 2021 and 2024.

The FDA has approved application ANDA078127 for an oral ondansetron solution (4 mg/5 mL) marketed by PAI Holdings, LLC dba PAI Pharma.

The FDA granted approval (status AP) for Vintage Pharms' ANDA078416 covering an oral solution of prednisolone sodium phosphate on Oct 31 2007; the product is listed as discontinued.

The FDA granted approval (AP) for ANDA 076672, an oral gabapentin solution 250 mg/5 ml submitted by TARO. The product is listed as discontinued.

The FDA has approved ANDA077849 for a fluoxetine oral solution (20 mg/5 mL) manufactured by Lannett Company, adding a new prescription product to the market.

The FDA has approved several labeling supplement submissions for the discontinued oral solution Levetiracetam (100 mg/mL) spanning from 2011 to 2024.