FDA Approves Two New Oral Treatments for HIV-1 Infection
Delstrigo is approved as a complete regimen whereas Pifeltro is to be administered in combination with other antiretrovirals.
Diagnosis & Disease Information
First Generic Version of EpiPen Gets FDA Approval
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.
FDA to Review Gimoti for Diabetic Gastroparesis in Adult Women
The FDA has set a Prescription Drug User Fee Act target date of April 1, 2019.
FDA Approves FreeStyle Libre 14 Day Flash Glucose Monitoring System
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.
Once-Monthly Perseris Approved for the Treatment of Schizophrenia
Perseris, an atypical antipsychotic, has an extended-release delivery system that releases sustained levels of risperidone over 1 month.
FDA to Review Novel Opioid Analgesic for Chronic Low Back Pain
This novel agent has low permeability across the blood-brain barrier, which slows its rate of entry into the brain and reduces dopamine release.
First Marijuana-Based Drug Approved to Treat LGS, Dravet Syndrome
This marks the first approved drug that contains an active ingredient derived from marijuana as well as the first treatment approved for patients with Dravet syndrome.
Post-Op Pain Treatment Gets Breakthrough Therapy Designation
The Company indicated that they will work towards an New Drug Application submission for the treatment in the second half of 2018.
Novel Antibiotic for C Difficile Infection Gets FDA’s QIDP Designation
ACX-362E is a targeted, narrow spectrum oral antibiotic that blocks the DNA replication process through inhibition of polymerase III, which has been shown to be bactericidal.
FDA Approves Non-Opioid Treatment for Opioid Withdrawal
Lucemyra is an oral selective alpha 2-adrenergic receptor agonist
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