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news.US-based generic topical pharmaceutical firm IGI Laboratories has received first approval from the US Food and Drug Administration (FDA) for an abbreviated new drug application (ANDA) of its lidocaine hydrochloride USP 4% topical solution.
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The solution is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.
IGI Laboratories president and CEO Jason Grenfell-Gardner said the FDA approval marks a true turning point in the transformation of the company.
"With our first drug approval, organically generated from beginning to end within IGI, we have validated our team’s ability to deliver on R&D," Grenfell-Gardner said.
"Although this particular drug is the smallest opportunity in our pipeline, it is an important milestone for demonstrating IGI’s capabilities.
"With now 13 further applications pending, and at least nine more filings planned this year, IGI will continue to execute its R&D plan as part of our goal of being a leading player in the generic topical pharmaceutical market."
IGI Laboratories develops and manufactures topical formulations for the pharmaceutical, OTC, and cosmetic markets.