The FDA has granted Perrigo approval for its azelastine hydrochloride nasal spray to address symptoms associated with seasonal allergies or environmental irritants among patients 12 and older. The medication is a generic equivalent of Astepro.
The FDA granted final approval to Perrigo's abbreviated new drug application for a generic version of fluticasone propionate lotion 0.05%, or cutivate lotion 0.05%. The treatment is indicated for the pruritic and inflammatory symptoms of atopic dermatitis in patients 1 year and older.
The FDA approved Perrigo's generic version of Fresenius Medical Care's PhosLo Gelcaps, a treatment for hyperphosphatemia in patients with end-stage renal disease on dialysis. Annual sales of PhosLo Gelcaps and generic versions total about $95 million, Perrigo said.
Perrigo applied for FDA approval to market a generic version of Meda Pharmaceuticals' allergy nasal spray Astepro, prompting the latter to file a patent-infringement lawsuit. Impax Laboratories helped with the regulatory filing and will share the cost and benefit.