Home Global Market Elite Pharmaceuticals Receives FDA Approval for Generic Sabril(R)

Elite Pharmaceuticals Receives FDA Approval for Generic Sabril(R)

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Summary :

Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, today announced that it received approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for a generic version of Sabril® (Vigabatrin USP) 500 mg powder for solution packet.

About Sabril(R)


Vigabatrin Structure

  • API – Vigabatrin
  • Indication – Complex partial epilepsy; Epilepsy; Infantile spasms
  • Class-Aminobutyric acids; Antiepileptic drugs; Drug withdrawal therapies; Small molecules
  • Mechanism of Action –Vigabatrin was rationally designed to have a specific effect on brain chemistry by inhibiting the GABA-degrading enzyme, GABA transaminase, resulting in a widespread increase in GABA concentrations in the brain. The increase in GABA functions as a brake on the excitatory processes that can initiate seizure activity.
vigabatrin Moa

Vigabatrin Moa

  • Orphan Drug Status-Yes – Infantile spasms; Epilepsy
  • Description : Vigabatrin is an antiepileptic drug indicated for refractory complex partial seizures and used as an adjunctive therapy in patients who have inadequately responded to several alternative treatments. Lannett Company, Inc. has an exclusive license to market and distribute the product in the U.S. and territories. Elite will exclusively manufacture and package the product for sale for an agreed-upon transfer price. The companies will share in product net profits.

About Lannett Company, Inc.

Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.

About Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops niche generic products. Elite specializes in developing and manufacturing oral, controlled-release drug products. Elite owns multiple generic products which have been licensed to Lannett Company, Prasco, LLC, Epic Pharma, LLC, and TAGI Pharma. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.

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