ANI Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Vancomycin Hydrochloride for Oral Solution in 250mg/5mL, a generic version of Vancocin.
Vancomycin is indicated to treat enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile.
“We are excited to re-launch this FDA approved product into a marketplace that is currently dominated by compounded vancomycin oral solutions,” said Arthur S. Przybl, ANI’s CEO. “We intend to pursue the removal of these unapproved compounded products from commercial distribution”
Vancomycin Hydrochloride for Oral Solution will be supplied in 80mL, 150mL, and 300mL package sizes.
The Company acquired Vancocin from Shire in 2014, along with the ANDA for vancomycin HCl for oral solution.
For more information visit anipharmaceuticals.com.