LCI stock is moving in pre-market trading on January 13, 2020, after the company announced that it received FDA approval for its Cocaine Hydrochloride Nasal Solution 4% product.
Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA), submitted under the 505(b)(2) regulatory pathway, for Cocaine Hydrochloride (HCl) Nasal Solution 4% (40 mg/mL), the company’s branded local anesthetic product.
“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 Tim Crew, chief executive officer of Lannett. “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®.”
NUMBRINO® (cocaine hydrochloride) nasal solution 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 505(b)(2) NDA submission was supported by two Phase III, randomized, double-blind, placebo-controlled, multicenter studies in several hundred patients, as well as a Phase I pharmacokinetic study.
On January 6, 2020, Lannett Company, Inc. (NYSE: LCI) announced that it has commenced marketing Venlafaxine Extended Release (ER) Tablets, 150 mg and 225 mg, USP, and Lidocaine Topical Solution 4%. The estimated IQVIA market values of Venlafaxine ER Tablets, 150 mg and 225 mg, USP, and Lidocaine Topical Solution 4% are approximately $150 million and $17 million, respectively, for the 12 months ending November 2019, although actual generic market values are expected to be lower.
“Both Venlafaxine ER Tablets and Lidocaine Topical Solution 4% are solid additions to our offering and add to our recent wave of product launches,” said Tim Crew, chief executive officer of Lannett. “Venlafaxine ER is a partnered product and the Lidocaine Topical Solution 4% is a product we acquired in May 2018 from a subsidiary of Endo International plc.”
On December 23, 2019, Lannett Company, Inc. (NYSE: LCI) announced that it received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Butalbital, Acetaminophen and Caffeine (BAC) Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg. The two dosage strengths of BAC Capsules, have a combined estimated IQVIA market value of approximately $68.6 million for the 12 months ending October 2019, although actual generic market values are expected to be lower.
“We have commenced marketing both dosage strengths of our newly approved BAC Capsules,” said Tim Crew, chief executive officer of Lannett. “Thus far in fiscal 2020, we have launched about half a dozen products, among them are Posaconazole, Prednisone and Cyproheptadine, and we expect to launch as many as 12 products in the coming six months.”
BAC Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg are the therapeutic equivalents of the reference listed drugs BAC Capsules, USP, 50mg/300mg/40mg and BAC Capsules, USP, 50 mg/325 mg/40 mg of Nexgen Pharma, Inc. and Mayne Pharma Inc., respectively.
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