Endo seeks tougher standards for generic versions of Lidoderm
CHADDS FORD, Pa. — Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.
The drug maker added an amendment to a citizen petition it filed with the FDA in 2006 concerning the drug Lidoderm (lidocaine), a patch used to treat post-herpetic neuralgia, a painful condition associated with shingles. The drug maker said the amended petition "highlights the growing scientific and regulatory support" for requiring clinical studies from generic drug makers looking to gain FDA approval for generic versions of such locally acting topical drugs as Lidoderm.
"Since we filed the original citizen petition in 2006, new studies and opinions from research scientists, as well as public statements from FDA officials, have further validated the need for comparative clinical endpoint studies to ensure a locally acting topical medication is bioequivalent to the branded product," Endo chief scientific officer and EVP research and development Ivan Gergel said. "FDA must publicly address the many unanswered questions from the original petition, as well as the additional concerns raised in this amendment, before taking any formal steps toward the approval of a generic version of Lidoderm."
Specifically, Endo said pharmacokinetic studies, which measure the level of a drug in the bloodstream, are not enough to demonstrate that a generic version of Lidoderm would be equivalent to the branded drug. The company also said that scientists had not identified any method other than clinical endpoint studies to show that drugs like Lidoderm and generic versions are equivalent and asked the agency to address allegations by another drug maker that the FDA had answered Endo’s 2006 petition in private correspondence, which Endo said would be illegal if it’s true.
HRG to present pharmacy design, OTC merchandising layout lecture at Campbell University
WAUKESHA, Wis. — Hamacher Resource Group announced that Tom Boyer, national account manager and co-owner at HRG, will be speaking to students in the pharmacy practice program at Campbell University this month.
Boyer, an 18-year veteran of the retail consumer healthcare industry, will present pharmacy layout, design, and over-the-counter merchandising to the program’s first-year students. The presentation is designed to help guide young pharmacists in operating a profitable front-end, and focuses on how to build customer loyalty and satisfaction as well as create an overall enjoyable shopping experience.
"We help pharmacists best serve their patients as well as run a profitable business," HRG VP Dave Wendland said. "Getting the front-end of the pharmacy right pays off in many ways and Tom does a great job of outlining the principles to give the students a real-life understanding of merchandising and store layout. It’s gratifying to hear that the students find it so valuable."
Supplylogix appoints former Safeway pharmacy leader
WESTLAKE, Texas — Healthcare supply chain software developer Supplylogix has appointed a former Safeway executive as its director of product development.
Supplylogix announced the hiring of Glen Davis, saying he would help expand the company’s suite of products that pharmacies and other healthcare providers use to improve supply chain performance.
"Supplylogix sets the standard for best-in-class supply chain software solutions to the pharmacy market," president and CEO Mark Wilgus said. "The deep supply chain, systems and operations experience that Glen has developed over his pharmacy leadership career will be invaluable to our clients as he accelerates execution on our product strategy."
Davis, who has worked in the pharmacy industry for more than 31 years, previously was group director of pharmacy services at Safeway and prior to that was VP pharmacy at Randall’s Food Markets.