On Monday, the FDA authorized Cumberland Prescribed drugs Inc’s CPIX supplemental New Drug Software (sNDA) for its Acetadote (N-acetylcysteine for injection) product.
Acetadote is an intravenous (IV) formulation of N-acetylcysteine (NAC) indicated to stop or reduce liver harm after ingestion of doubtless poisonous portions of acetaminophen.
Acetaminophen, a standard over-the-counter ache reliever and fever reducer, is the main explanation for acute liver failure in america.
Every year, 1000’s of people expertise unintentional or intentional acetaminophen poisoning, resulting in severe liver harm.
The newly authorized dosing routine simplifies the administration of Acetadote by combining the primary two luggage of the usual routine right into a single, slower infusion.
This streamlined method has been carried out in hospitals throughout a number of international locations. It has been demonstrated to scale back the frequency of remedy errors and doubtlessly severe non-allergic anaphylactoid reactions (NAARs) with out compromising the effectiveness of Acetadote.
By simplifying the dosing routine, healthcare suppliers can administer the life-saving therapy extra effectively, doubtlessly bettering affected person outcomes.
For the third quarter, Cumberland Prescribed drugs reported internet revenues of $9.1 million, down from $10.1 million a yr in the past.
Final month, the FDA granted Orphan Drug Designation and Uncommon Pediatric Illness Designation to Ifetroban for cardiomyopathy related to Duchenne muscular dystrophy (DMD).
Cumberland is finishing the FIGHT DMD Section 2 trial investigating the pharmacokinetics, security, and efficacy of as soon as every day oral Ifetroban in sufferers with DMD. Outcomes will probably be introduced later this yr.
Value Motion: CPIX inventory is up 142.7% at $3.01 on the final test on Tuesday.
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