FDA approves three generic drug applications, four submissions, across Amneal and ANI Pharms
FDA actions this week covered sodium phosphates, mesalamine, and an ADHD stimulant combination, with two separate approvals for the same ANI Pharms application.
FDA cleared four submissions across three generic drug applications this week.
- Amneal received original approval for a sodium phosphates injection. The product is an intravenous solution combining sodium phosphate dibasic heptahydrate (4.02GM/15ML) and sodium phosphate monobasic monohydrate (4.14GM/15ML), approved under ANDA218274 with standard review priority.1
- Amneal also won a labeling supplement for its mesalamine delayed release tablet. The 800MG oral tablet, filed under ANDA215067 as submission number 6, was approved with standard review priority.2
- ANI Pharms received two separate labeling supplement approvals for the same extended release capsule combination of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate. Submission number 14 for ANDA205401 covered multiple capsule strengths from 1.25MG to 7.5MG per active ingredient and was approved with standard review priority.3 Submission number 19 for the same application, ANDA205401, covering the identical set of capsule strengths, was also approved with standard review priority.4
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.