Levofloxacin oral solution 25mg/mL is the generic for McNeil Pharmaceutical’s Levaquin oral solution.
The solution is indicated for the treatment of adults with mild, moderate and severe infections.
Hi-Tech specializes in difficult to manufacture liquid and semi-solid dosage forms and produces a range of sterile ophthalmic, otic and inhalation products.
The company’s Health Care products division develops branded prescription and OTC products for the diabetes marketplace.
The company filed the ANDA pursuant to 505(j)(2)(A)(vii)(IV) of the Food Drug and Cosmetic Act and the FDA confirmed that Hi-tech will have 180 day related to its Paragraph IV patent challenge.
Hi-Tech has 20 products in active development targeting brand sales of over $4bn, including sterile ophthalmic products, oral solutions and suspensions and nasal sprays.