Ranbaxy Pharmaceuticals Inc (RPI), a fully owned subsidiary of Ranbaxy Laboratories Ltd in the US, today announced that it has got a tentative approval from the US Food and Drug Association for commercialisation of midazolam syrup, 2mg(base)/ml.
According to a Ranbaxy statement, this is the first tentative approval for this product granted to a generic pharmaceutical company. Midazolam has been deemed to be a bio-equivalent of Versed, a registered trademark of Hoffman LaRoche.
"This product represents yet another addition to the expanding portfolio of RPI. The company's offerings consists of not only solids but also a growing number of products available in the liquid form and other value-added dosage forms," the statement added.
Midazolam syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia under a monitored environment only and not for clinical or home use. It is available in injectible form as well as a syrup for oral administration. Midazolam sales totalled $220 million during 2000.
The tentative approval is the eighth ANDA (abbreviated new drug application) nod for Ranbaxy during the year. RPI was awarded this approval in 12 months, which the company claims is much below the average approval time reported by other generic companies.
"The tentatively approved formulation is the result of research & development efforts that focused on the active pharmaceutical ingredient and the bio-equivalent formulation, both of which were developed through the scientific capabilities within the Ranbaxy Research Laboratories, Gurgaon," the statement said.
The product, which is currently under NDF exclusivity and pediatric exclusivity, will come off patent on April 15, 2002.
Ranbaxy anticipates that the final approval to its offering will come around the same time. Subsequently, RPI plans to launch the product in the US in all classes of trade. Sales will focus on a single size SKU (store keeping unit) of 118 ml which duplicates the innovator for this controlled substance. The sales and marketing will be handled by RPI's commercial team.
