• COVID-19
  • Biosimilars
  • Cataract Therapeutics
  • DME
  • Gene Therapy
  • Workplace
  • Ptosis
  • Optic Relief
  • Imaging
  • Geographic Atrophy
  • AMD
  • Presbyopia
  • Ocular Surface Disease
  • Practice Management
  • Pediatrics
  • Surgery
  • Therapeutics
  • Optometry
  • Retina
  • Cataract
  • Pharmacy
  • IOL
  • Dry Eye
  • Understanding Antibiotic Resistance
  • Refractive
  • Cornea
  • Glaucoma
  • OCT
  • Ocular Allergy
  • Clinical Diagnosis
  • Technology

Two Akorn solutions approved by FDA

Article

Akorn Inc. has received FDA approval of its abbreviated new drug applications for 0.1% diclofenac sodium ophthalmic solution and 0.3% ofloxacin ophthalmic solution USP.

Buffalo Grove, IL-Akorn Inc. has received FDA approval of its abbreviated new drug applications for 0.1% diclofenac sodium ophthalmic solution and 0.3% ofloxacin ophthalmic solution USP.

Diclofenac is a non-steroidal anti-inflammatory agent used to treat patients undergoing cataract and refractive surgery. Annual sales for the solution were approximately $14 million in 2007, according to IMS sales data.

"This is our first product approval in 2008 for our Somerset, NJ, facility," said Arthur S. Przybyl, Akorn's president and chief executive officer. The company expects to launch diclofenac in the second quarter of this year, he added.

The ofloxacin solution will be manufactured in the company's Decatur, IL, facility, said Przybyl, who added that the company plans to launch the product in the third quarter of this year.

Related Videos
Katherine Talcott, MD, presenting slides
Katherine Talcott, MD, presenting slides
© 2024 MJH Life Sciences

All rights reserved.