FDA gives tentative approval for Perrigo OTC pain drugs

ALLEGAN, Mich. The Food and Drug Administration has given Perrigo tentative approval for its OTC ibuprofen and diphenhydramine citrate tablets, Perrigo announced Wednesday.

The product, available in 200 mg and 38 mg doses, will be sold under private labels and is comparable to Wyeths Advil PM pain-relief tablets.

“This is another example of Perrigo’s investment in new products making quality healthcare more affordable to American consumers,” Perrigo chairman and chief executive officer Joseph Papa said in a statement. “This is an important addition to our portfolio of products that saves the consumer of our OTC healthcare products approximately $1 billion annually when compared to the higher priced national brands.”