Spectrum files 13th abbreviated New Drug Application

By Elaine Rigoli

Tampa, Fla., March 13 - Spectrum Pharmaceuticals, Inc. said it has filed its 13th abbreviated New Drug Application (aNDA), which is for an injectable drug, with the Food and Drug Administration.

Spectrum currently has nine other aNDAs that are under review at the FDA, including an aNDA with paragraph 4 certification for sumatriptan succinate injection, the generic form of GlaxoSmithKline's Imitrex injection, according to a news release.

As announced last month, Spectrum's generic product line will be distributed by Par Pharmaceutical Cos. Inc.

Spectrum said it will receive certain milestone payments on achievement of regulatory approvals and the parties will share the profits from the sale of Spectrum's generic products.

In addition, Par will provide financial and legal support for the ongoing patent challenge for sumatriptan injection, the release said.

Spectrum, located in Irvine, Calif., is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drug products for the treatment of cancer and other unmet medical needs.

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