Final OK for OTC omeprazole, and Perrigo ups guidance
The US Food and Drug Administration has granted final approval to drug delivery specialists Dexcel Pharma Technologies for 20mg omeprazole delayed-release tablets. As the exclusive marketer and distributor of this product for the store brand over-the-counter market in the USA, drugmaker Perrigo expects to begin shipping its product during the first quarter of calendar year 2008, with full-year annual sales to be in the range of $150.0 million-$200.0 million.
Perrigo's chief executive, Joseph Papa stated that "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."
Based on pre-launch estimates, Perrigo's omeprazole product is expected to contribute between $0.20 and $0.25 earnings per share in fiscal year 2008. As a result of the launch, full-year earnings are expected to be in the range of $1.32 to $1.47 per share.
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