Lannett Company announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Butalbital, Acetaminophen, and Caffeine Tablets, the generic of Watson‘s Fioricet. It consists of Butalbital 50mg, Acetaminophen 325mg, Caffeine 40mg.
Fioricet tablets are a combination of a barbiturate and an analgesic, and are indicated for tension (or muscle contraction) headaches. Butalbital is a short-acting barbiturate with anticonvulsant and sedative properties. Caffeine is a cranial vasoconstrictor that potentiates analgesia.
The company expects to ship the product next month.
For more information call (215) 333-9000 or visit www.lannett.com.