FDA approves Eisai’s BANZEL® as an adjunctive treatment of seizures in kids (Age 1-4) with LGS

By:
 
Feb. 13, 2015 - PRLog -- The U.S. Food and Drug Administration (FDA) approved supplemental New Drug Application (sNDA) for Eisai’s BANZEL®(rufinamide) to be used as an adjunctive treatment of seizures in pediatric patients one to four years old with Lennox-Gastaut Syndrome (LGS). Banzel is already approved as an adjunctive treatment of seizures linked to LGS in kids age four years and older and adults.

"The approval of BANZEL for pediatric patients, one to four years of age, represents an important milestone, as it may help to address an unmet need of younger patients with Lennox-Gastaut Syndrome," said Lynn Kramer, Chief Clinical Officer (ECL) and President, Neuroscience & General Medicine, PCU Eisai Product Creation Systems, Eisai Inc. "At Eisai, we are committed to our corporate human health care (hhc) mission and are proud to help serve patients and families living with this rare condition."

FDA approval was based on pharmacokinetic bridging study of a Phase III clinical trial (study 303) in patients 1 to 4 years of age.  According to the study the pharmacokinetic and safety profiles are consistent with those seen in ages 4 and above.

With such industry leaders paving the way with new, beneficial therapeutic breakthroughs, they will need both certified and qualified individuals to promote their diversified product portfolio. When industry leaders look for new candidates for sales/marketing positions, they look toward individuals that are industry trained. Companies are looking for people that have the background to sell their product both proficiently and efficiently. The CNPR is a federally trademarked certification you can earn by demonstrating the necessary knowledge in pharmacology, medical terminology, physiology, and regulations for selling pharmaceuticals. The CNPR examination is dedicated to increasing the professional level of NAPSR members and to developing meaningful and ethical standards fully accepted by both its members and members of the pharmaceutical community.

Individuals that are interested in becoming a Certified National Pharmaceutical Representative (CNPR) can contact the National Association of Pharmaceutical Sales Representatives(NAPSRx) for more information or visit the website at http://napsronline.org/

Contact
NAPSRx
***@napsronline.org
1-800-284-1060
End
Email:***@napsronline.org Email Verified
Tags:Napsrx, Cnpr Certification, Fda Approval, Pharmaceutical Sales Rep, Training
Industry:Biotech, Health
Location:Georgia - United States
Account Email Address Verified     Account Phone Number Verified     Disclaimer     Report Abuse



Like PRLog?
9K2K1K
Click to Share