Industry Press Releases

Mayne Pharma Launches Butalbital Acetaminophen Tablets In The United States

Friday, Feb 17, 2017
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Mayne  Pharma  Group  Limited is  pleased  toannounce the launch  of butalbital  acetaminophen (APAP)tablets50mg/300mgin  the  United States. Butalbital / APAPis indicated for the treatment of tension headache (migraine).

Mayne  Pharma  will distribute  the  drug  on  behalf of its  partner, Mikart  Inc.which developed  the product and is also
manufacturing the product.

According  to  IMS  Health,  US  brand  sales wereapproximately  US$27million  for  the  12months ending 31December 2016.  

Mayne Pharma’s CEO, Mr Scott Richards, said “We are very pleased to have licensed this product from Mikart, Inc, one of our strategic partners.This will be the first generic alternative to BUPAP®and will bring patients and payers improved medication affordability.”

Mayne  Pharma continues  to  aggressively  expand  its  product  portfolio  throughinternal  product development,  strategic  acquisition,  in-licensing  and  working  collaboratively  with  partners  like Mikart. Today, the Company directly markets more than 50 products and has a growing pipeline of more than 40 generic and branded drug products targeting US markets with IMS sales greater than US$6 billion.

For further information contact:Lisa Pendlebury   +61 419 548434,lisa.pendlebury@maynepharma.com

About Mayne Pharma
Mayne  Pharma  is  an  ASX-listed  specialty  pharmaceutical  company  focused  on  applying  its  drug  delivery expertise  to  commercialise  branded  and  generic pharmaceuticals providing  patients  with  access  to  better and  more  affordable  medicines.Mayne  Pharma  also  provides  contract development  and  manufacturing services to more than 100 clients worldwide.

Mayne  Pharma  has  a  30-year  track  record  of  innovation  and  success  in  developing  new  oral  drug  delivery systems and these technologies have beensuccessfully commercialised in numerous products that have been marketed around the world.

Mayne Pharma has two productdevelopment and manufacturing facilities basedin Salisbury, Australia andGreenville,   USA with expertise in theformulation ofcomplex oral dose forms including highly  potent compounds, controlled substances, modified-release products and inherently unstable compounds.Bupap® is a registered trademark of ECR Pharmaceuticals Co., Inc.

Warning
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.  Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product

Acetaminophen Indication and Usage
Butalbital and acetaminophen tablets, 50mg/300mg are indicated for the relief of the symptom of complex tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable.  Caution in this regard is required because Butalbital is habit-forming and potentially abusable.

Selected Safety Information about Butalbital and acetaminophen tablets,50mg/300mg.Hepatotoxicity: Acetaminophenhas been associated with cases of acute liver failure, at times resulting in liver transplant and death.  Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing
product.  

Butalbital acetaminophen tablets, 50mg/300mg is contraindicated under the following conditions:
* Hypersensitivity or intolerance to any component of this product.
* Patients with porphyria.
* Butalbital is habit-forming and potentially abusable.  Consequently, the extended use of this product is not      recommended.
* The risk of acute liver failure is higherin individualswith underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
* Acetaminophen may cause serious skin reactions such as acute generalizedexanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.  Full prescribing information, including warnings, can be found here.

To report a suspected adverse reaction from one of our products, please contact Mayne Pharma at 1-844-825-8500 or
maynepharmamc@dlss.com, or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.  

 

Source:maynepharma.com

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