Amityville-based Hi-Tech Pharmacal Co. has final approval from the U.S. Food and Drug Administration for a new generic version of the anti-anxiety drug lorazepam, the company said Tuesday.
Hi-Tech's newly approved drug application is for lorazepam oral concentrate, the generic for Roxanne’s Lorazepam Intensol, and it plans to launch the product by May.
The drug, in the benzodiazepine class of anxiety remedies, is made in a highly concentrated liquid form, administered with a dropper alone or added to juice, water or soda, according to the National Institutes of Health's National Library of Medicine.
The drug had combined brand and generic sales of $10 million last year, Hi-Tech said.
Lorazepam is prescribed for anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depression.
The drugmaker said it is seeking FDA approval for 15 other products with a combined annual market of more than $1.5 billion. It also has 20 products in active development, with annual markets of more than $3 billion.
Hi-Tech Pharmacal specializes in producing hard-to-manufacture semisolid and liquid medicines for the eye, ear, nose and throat. It makes generic and branded products.