Lannett gets FDA nod for Numbrino
Lannett has received the Food and Drug Administration’s clearance for Numbino (cocaine hydrochloride nasal solution 4%)
The branded product is an ester local anesthetic indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.
"The FDA's approval of our cocaine HCl product, the first NDA approval to include full clinical trials in the company's history, marks a major milestone in Lannett's 70+ years of operations," said Lannett CEO Tim Crew.
Crew added, “We believe the product has the potential to be an excellent option for the labeled indication. We expect to launch the product shortly, under the brand name Numbrino."