The expanded approval was supposed by safety and efficacy data from the Phase 3 ACCESS IUS trial (N=1751) in women receiving Liletta. In the trial, Liletta demonstrated >99% efficacy in preventing pregnancy for up to 5 years in a broad patient population.
Eravacycline was well-tolerated in clinical trials and achieved high cure rates in patients with Gram-negative pathogens (including resistant strains).
Cassipa combines buprenorphine, an opioid (partial agonist-antagonist), and naloxone, an opioid antagonist.
Delstrigo is approved as a complete regimen whereas Pifeltro is to be administered in combination with other antiretrovirals.
A Phase 1 study in healthy volunteers showed a favorable safety profile with no serious adverse events.
The FDA has set a Prescription Drug User Fee Act target date of April 1, 2019.
Unlike other generic approvals, epinephrine auto-injectors are considered “combination products” because they consist of both a drug and a device, making the approval process more challenging.
The new Flash Glucose Monitoring System enables patients to wear the sensor for up to 14 days compared with the existing FreeStyle Libre System that was approved for 10-day wear.
Perseris, an atypical antipsychotic, has an extended-release delivery system that releases sustained levels of risperidone over 1 month.
This novel agent has low permeability across the blood-brain barrier, which slows its rate of entry into the brain and reduces dopamine release.
