IGI Laboratories, Inc., generic topical pharmaceutical company, has received formal approval from the US Food and Drug Administration (FDA) of its supplemental filing for the site transfer of econazole nitrate cream one per cent, to the company's manufacturing facility in Buena. IGI had purchased econazole nitrate cream one per cent from Prasco, LLC in February of 2013.
Jason Grenfell-Gardner, president and CEO of the Company, commented, "This approval marks the first time the FDA has granted an approval to an IGI own-label project. In less than eight months, we successfully completed all the required steps to achieve approval from the FDA to manufacture our first proprietary IGI label product. This accomplishment is a testament to the dedication and efforts of our entire team. We are currently actively manufacturing, marketing and selling this product through our existing commercial infrastructure."
IGI Laboratories develop and manufacture topical formulations for the pharmaceutical, OTC, and cosmetic markets and a leading player in the generic topical prescription drug market.