At Spectrum, we believe in operating a “risk reduced” business model. With an opportunity to potentially enhance Spectrum's financial resources while establishing important relationships and brand awareness with health care providers, Spectrum is currently building a generic drug portfolio. The Company's current collection of generic drugs covers multiple platforms, including injectable and ophthalmic products. In February 2006, Spectrum entered a strategic alliance with Par Pharmaceutical Companies, Inc. for the sale and distribution of current and future generic drugs developed by Spectrum.
To date, Spectrum has filed fourteen Abbreviated New Drug Applications (ANDA) and received final regulatory approval for three drugs, ciprofloxacin tablets, carboplatin "ready-to-use" liquid injection, and fluconazole tablets.
In October 2004, we filed with the FDA an ANDA with Paragraph IV certification for sumatriptan succinate injection 6mg/0.5mL, seeking approval to engage in the commercial manufacture, sale, and use of the sumatriptan succinate injection product in the United States. Sumatriptan succinate is marketed by GlaxoSmithKline under the brand name Imitrex® and is used for the acute treatment of migraine attacks with or without aura and the acute treatment of cluster headache episodes in adults.
By filing this ANDA, we initiated a challenge of a patent listed by GlaxoSmithKline in connection with Imitrex® Injection. For more information on the patent challenge process under the Hatch-Waxman Act, please visit our annual report on Form 10-K.
