Acetaminophen/butalbital/caffeine is used in the treatment of headache and belongs to the drug class analgesic combinations. Risk cannot be ruled out during pregnancy. Acetaminophen/butalbital/caffeine 325 mg / 50 mg / 40 mg is not a controlled substance under the Controlled Substance Act (CSA).
Fioricet and is a round, blue tablet; but is not the Westward brand I usually receive. This tablet has the letters LCI printed on one side and the numbers 1655 on the other side
Drug Class:Analgesic combinationsPregnancy Category:C – Risk cannot be ruled out
CSA Schedule: Not a controlled drug Manufacturer : Lannett Company, Inc.
Lannett Company, Inc. was Founded in 1942, Lannett develops, manufactures and distributes generic prescription pharmaceutical products in tablet, capsule and oral liquid forms to customers throughout the United States. Lannett markets its products primarily to drug wholesalers, retail drug chains, distributors, and government agencies.
We employ a staff of dedicated people who work together to produce drug products that sick people can afford to buy that will treat their illness, make them well, reduce suffering and improve the quality of their lives.
PHILADELPHIA–(BUSINESS WIRE)–Lannett Company, Inc. (NYSE MKT: LCI) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Butalbital, Acetaminophen and Caffeine Tablets, USP, 50mg/325mg/40mg. According to IMS, for the year ended July 2012 total sales of Butalbital, Acetaminophen and Caffeine Tablets at Average Wholesale Price (AWP) were approximately $30 million, of which about $15 million was for the brand version, Fioricet®. The company expects to commence shipping the product next month.
“Sales of Butalbital, Acetaminophen and Caffeine Tablets have been climbing five percent annually over the past three years,” said Arthur P. Bedrosian, president and chief executive officer of Lannett. “This approval continues the positive momentum we have generated over the last several quarters. We have a number of product applications pending at the FDA, including several late-stage, large market opportunity drugs. Our active product development program is focused on expanding our pain management franchise. We thank our local FDA representatives, as well as the reviewers at the Office of Generic Drugs, who were helpful in getting our product applications approved.”
About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of indications. For more information, visit the company’s website at www.lannett.com.
This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statements, including, but not limited to, successfully commercializing Butalbital, Acetaminophen and Caffeine Tablets, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the difficulty in predicting the timing or outcome of FDA or other regulatory approvals or actions, the ability to successfully commercialize products upon approval, Lannett’s estimated or anticipated future financial results, future inventory levels, future competition or pricing, future levels of operating expenses, product development efforts or performance, and other risk factors discussed in the company’s Form 10-K and other documents filed with the Securities and Exchange Commission from time to time. These forward-looking statements represent the company’s judgment as of the date of this news release. The company disclaims any intent or obligation to update these forward-looking statements.