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Leucadia Pharmaceuticals launches FDA-approved dihydroergotamine mesylate nasal spray

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CARLSBAD, Calif. – Leucadia Pharmaceuticals, a U.S. innovator of generic drug products and the commercial arm of Custopharm, Inc., announced the launch of its latest first-to-market generic, dihydroergotamine mesylate nasal spray. The FDA-approved nasal spray, now available to patients, is therapeutically equivalent to MIGRANAL and is used for acute treatment of migraine headaches with or without aura. It is AB-rated, bar- coded, preservative-free and does not contain natural rubber latex.

“Dihydroergotamine mesylate nasal spray is the latest example of Leucadia’s continued commitment to providing safe, effective solutions that increase patient quality of life,” said Dr. William Larkins, Chief Executive Officer of Leucadia Pharmaceuticals’ parent company, Custopharm. “This generic is Leucadia’s third product since April 2019 to receive first generic approval from the Food and Drug Administration, a unique achievement that serves as a testament to the tireless work of our dedicated team.”

In April 2019, Leucadia was the first generic drug manufacturer to receive FDA approval for the antineoplastic agent Valrubicin Intravesical Solution, USP, a generic alternative therapeutically equivalent to VALSTAR. Eight months later Leucadia received approval for the only generic FDA-approved Sodium Tetradecyl Sulfate (STS). This regulated sclerosing agent is used to treat small varicose veins of the lower legs and is therapeutically equivalent to SOTRADECOL as a safe and effective alternative to the use of unapproved compounded products.

Over the last year, Leucadia has also launched Icatibant Injection, an FDA-approved generic for FIRAZYR, used to treat hereditary angioedema (HAE) and Dicyclomine HCl Injection, USP, an FDA-approved generic antispasmodic and anticholinergic (antimuscarinic) agent equivalent to Bentyl, used to treat functional bowel/irritable bowel syndrome (IBS).

“Leucadia continues to prioritize the development of high barrier products and this latest first generic launch demonstrates that yet again,” said Dr. Larkins. “In addition to the seven commercial products actively being marketed we remain committed to bringing even more of these new solutions to market in the years to come.”


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