Hi-Tech Pharmacal has acquired the rights to the Abbreviated
New Drug Application (ANDA) for Nystatin Oral suspension from Bausch + Lomb,
the global eye health company for an undisclosed upfront payment and a future
royalty.
Nystatin oral suspension is indicated for the treatment of
candidiasis in the oral cavity. The market for Nystatin oral solution was $23 million
based on IMS data. Hi-Tech intends to launch Nystatin oral solution in all
commercially available fill sizes as soon as it satisfies all applicable FDA
requirements.
Hi-Tech currently has 14 products awaiting approval at the
FDA, targeting brand and generic sales of approximately $1.0 billion. In addition,
Hi-Tech has 20 products in active development targeting brand sales of over $3
billion, including sterile ophthalmic products, oral solutions and suspensions
and nasal sprays.