FDA approves Boca Pharmacal's Hydrocodone Bitartrate and Acetaminophen Oral Solution ANDA

Boca Pharmacal, Inc., today announced that it has received approval from the FDA of its Abbreviated New Drug Application (ANDA) for Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5mg / 325mg per 5mL, the generic version of Hycet® Oral Solution distributed by FSC Laboratories, Inc. Hydrocodone Bitartrate and Acetaminophen Oral Solution is used for treatment for the relief of moderate to moderately severe pain.

"This is our second approval this year," said Robert Edwards, CEO of Boca Pharmacal. "And we expect more by year's end. We have already filed a few ANDAs since January, an impressive feat for a small privately held pharmaceutical company."