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www.fdanews.com/articles/91641-fda-approves-boca-pharmacal-s-generic-version-of-panlor-ss

FDA Approves Boca Pharmacal's Generic Version of Panlor SS

April 11, 2007

Boca Pharmacal announced that the FDA granted final approval to the company's abbreviated new drug application (ANDA) for its generic version of Panlor SS. The company said it plans to launch the product immediately.

Panlor SS, made by Pan American Laboratories, is used to treat moderate to severe pain. Each tablet contains acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine 32 mg.

"Our latest approval represents another significant advancement for our company by increasing our generic product offerings and value-priced alternatives for consumers," Robert Edwards, chairman and CEO of Boca Pharmacal, said. "In addition to the approval of generic Panlor SS, we expect five more approvals as well as filing 14 ANDA submissions during 2007."