Perrigo gets final FDA approval for generic Prilosec

ALLEGAN, Mich. Perrigo Monday evening announced that the Food and Drug Administration has granted final approval to Dexcel Pharma Technologies for its 20 mg omeprazole delayed-release tablets, which means Perrigo expects to begin shipping generic equivalents to Procter & Gamble’s Prilosec OTC during the first quarter.

“The approval from the FDA is the final regulatory step for this exclusive product launch, which we expect to be the largest product in Perrigo’s 120 year history,” stated Joe Papa, Perrigo chairman and chief executive officer.

Perrigo expects full-year annual sales to fall between $150 million and $200 million.

Prilosec OTC is indicated for the treatment of frequent heartburn and had estimated current annual sales of approximately $750 million in all outlets, Perrigo stated.