ANI Launches Vancomycin Hydrochloride for Oral Solution

ANI Pharmaceuticals announced the launch of Vancomycin HCl for Oral Solution, 250mg per 5mL (the generic equivalent to ANI's Vancocin® for Oral Solution). To facilitate ease of administration the drug now includes a mixed berry taste, can be administered via nasogastric tube and does not contain any ingredients made with gluten-containing grain (wheat, barley, rye). The dye-free product is delivered in a single bottle format requiring simple reconstitution and offers dosing flexibility achieved through the availability of three different size bottles: 80mL, 150mL and 300mL. ANI estimates that the current annual U.S. vancomycin market is approximately $450 million.

"This launch represents yet another successful re-commercialization for ANI of a previously discontinued drug and is our fourth generic product introduction in 2019,” Arthur S. Przybyl, ANI's President and CEO said. “Our launch of Vancomycin for Oral Solution addresses an unmet need in the treatment of staph and C-diff infections and provides patients, physicians and pharmacists with a convenient, FDA-approved oral solution of vancomycin in addition to the currently available capsule and injectable forms. We are supporting this launch with an awareness campaign that leverages the existing virtual marketing infrastructure that we use to support our brand portfolio.

Vancomycin Hydrochloride for Oral Solution is a prescription medication administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by Clostridium difficile. Parenteral administration of vancomycin is not effective for the above indications; therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral Solution is not effective for other types of infection.

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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Oral Solution and other antibacterial drugs, Vancomycin Hydrochloride for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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