The 5 Latest FDA Drug Approvals

July 14, 2017

The FDA has already approved 24 new drugs in 2017. Here's what you need to know about the latest 5.

The FDA has had a busy 2017. In 2016 they approved only 22 novel drugs. It’s July and they’ve already approved 24.

From the first new drug to treat ALS in over two decades to new eczema treatment to several new cancer drugs, this year has seen an explosion in both orphan and nonorphan drugs. With the recent promise to start clearing all new orphan drug applications in 90 days, 2017 could see a glut of new drugs.

We’ve already brought you the last ten newly approved drugs and the nine before that. Here is what you need to know about the five latest drugs.

 

RADICAVA (edaravone injection), MT Pharma America

Indications: Treatment of amyotrophic lateral sclerosis (ALS)

Dosage: 60 mg administered as an intravenous infusion over 60 minutes; Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period; Subsequent treatment cycles: daily dosing for 10 days out of 14- day periods, followed by 14-day drug-free periods.

Contraindications: Patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in RADICAVA.

Read the full label here

 

KEVZARA (sarilumab), Regeneron

Indications: The treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).

Dosage: May be used as monotherapy or in combination with methotrexate or other conventional DMARDs. 200 mg once every 2 weeks, administered as a subcutaneous injection.

Contraindications: Patients with known hypersensitivity to sarilumab or any of the inactive ingredients.

Check out the Drug Topics New Drug Review here

Read the full label here

 

 

BAXDELA (delafloxacin), Melinta Therapeutics

Indications: Treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria in adults.

Dosage: 300 mg by intravenous infusion over 60 minutes, every 12 hours, or a 450-mg BAXDELA tablet orally every 12 hours for 5 to 14 days total duration.

Contraindications: Known hypersensitivity to BAXDELA or other fluoroquinolones.

Read the full label here

 

 

BEVYXXA (betrixaban), Portola Pharma

Indications: Prophylaxis of venous thromboembolism (VTE) in adult patients.

Dosage: An initial single dose of 160 mg, followed by 80 mg once daily, taken at the same time each day with food.

Contraindications: Active pathological bleeding, severe hypersensitivity reaction to betrixaban.

Read the full label here

 

 

TREMFYA (guselkumab), Janssen

Indications: Treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Dosage: Injection: Subcutaneous injection, 100 mg/mL in a single-dose prefilled syringe.

Contraindications: None.

Read the full label here