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.
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 FDA has set a Prescription Drug User Fee Act target date of April 1, 2019.
Perseris, an atypical antipsychotic, has an extended-release delivery system that releases sustained levels of risperidone over 1 month.
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.
This novel agent has low permeability across the blood-brain barrier, which slows its rate of entry into the brain and reduces dopamine release.
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.
The Company indicated that they will work towards an New Drug Application submission for the treatment in the second half of 2018.
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.
Lucemyra is an oral selective alpha 2-adrenergic receptor agonist
The efficacy of Aimovig was evaluated as a preventive treatment of episodic or chronic migraine in 3 randomized, double-blind, placebo-controlled studies: 2 studies in patients with episodic migraine (4-14 migraine days per month) and 1 study in patients with chronic migraine (≥15 headache days per month with ≥8 migraine days per month).
Gilenya is the first multiple sclerosis drug approved for children
The FDA advisory committee voted 12-2 in favor of recommending the approval of Nuplazid.
Switching back to branded drugs is more likely in generic drug than authorized generic drugs.
The FDA has approved Rubraca, a poly (ADP-ribose) polymerase inhibitor, to treat patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The proposed pediatric indications are based on a 2018 Draft Guidance that supports extrapolating efficacy data of approved drugs to treat POS in adults to pediatric patients aged ≥4 years.
Does weak evidence drive the NCCN recommendations of FDA-approved drugs?
A new antiretroviral HIV treatment, Trogarzo (ibalizumab-uiyk), has been approved by the FDA for patients with HIV who have not have success with past HIV medications.
The new FDA approved short-acting insulin drug can be used to treat T1 and T2 diabetes.
The FDA has approved two new treatments, Tresiba and Ryzodeg, for both type 1 and type 2 diabetes.
The drug is approved for patients who are unable to control their LDL cholesterol with current treatment options.
The FDA approval of a pediatric indication for Oxycontin creates a safer situation for terminally ill children.
The FDA has approved a pediatric indication for OxyContin in patients as young as 11 years.
An intragastric balloon receives approval as a non-surgical weight loss procedure for patients with mild-to-moderate obesity.
Two new therapies to treat irritable bowel syndrome, eluxadoline and rifaximin, have been approved by the FDA.
Spray-dried fibrin sealant promotes clotting when other methods are "ineffective or impractical."