Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced that it 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.