FDA Approves Abbreviated New Drug Application for Levofloxacin Oral Solution

The US Food and Drug Administration (FDA) approved Lannett Company’s Abbreviated New Drug Application (ANDA) for levofloxacin oral solution USP, 25 mg/mL, which is the therapeutic equivalent to the reference listed drug, Janssen Pharmaceuticals’ levaquin oral solution USP, 25 mg/mL.

“Our ANDA for Levofloxacin Oral Solution, a paragraph IV product, was approved 3 weeks ahead of the Target Action Date,” Lannett’s CEO Tim Crew said in a recent statement. “While the commercial opportunity for our levofloxacin product is modest, the expected near-term launch is further evidence of our growing operational effectiveness.”

Lannett expects to announce additional product launches in the coming months, he added.

A fluoroquinolone antibiotic medicine, levofloxacin is indicated for adults who are 18 years of age or older who have certain bacterial infections, including types of pneumonia and bronchitis. Levofloxacin can also treat chronic prostate infection, urinary tract infection, uncomplicated acute kidney infection, sinus infection, and skin infections. Additionally, the antibiotic can also be used to treat inhalation anthrax and even plague.

A previous version of this article appeared on PharmacyTimes.com.