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Sheryl Underwood, Depend brand partner for awareness campaign

BY Ryan Chavis

DALLAS — Talk show host and comedienne Sheryl Underwood is teaming up with Depend brand to share her experience with bladder leakage as part of Drop Your Pants for Underwareness. The iniative is an effort to break down the stigma of bladder leakage and support those who experience it, the company said.

“As an entertainer, I was taught how to be in the spotlight but no one ever prepared me for living with bladder leakage when you’re 50 years young,” said Underwood, who is featured on the daytime show The Talk on CBS. “There’s no name or face or age on this, and I hope that by sharing my story and joining Depend in Underwareness, I will inspire others and help them feel less alone.”

Underwood's testimonay is featured on Underawareness.com. The brand will donate $1 (up to $3 million) over the next three years to charities for:

  • Every pant drop, photo and video shared and tweet tagged using #Underwareness and #DropYourPants; and
  • Every personal video made about what Underwareness means to you that is uploaded to YouTube and tagged #Underwareness and #DropYourPants.

“We’re thrilled Sheryl Underwood was open to sharing her personal story in support of Underwareness,” said Elizabeth Metz, Depend brand director, Kimberly–Clark. “It’s very powerful to have a high profile person like her helping to change the stigma of bladder leakage and Depend Underwear. Sheryl’s a perfect example of how bladder leakage doesn’t have to slow people down.”

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Alliance Boots acquires full ownership of the UniDrug Distribution Group

BY Michael Johnsen

BERN, Switzerland – Alliance Boots on Monday announced it has acquired full ownership of UniDrug Distribution Group, its pre-wholesale and contract logistics joint venture in the United Kingdom, from UDG Healthcare for a consideration of around £66 million ($110.4 million) for the 50% shareholding it did not already own. 
 
The joint venture is already part of the Alloga pan-European network and will shortly be rebranded to Alloga.
 
“Acquiring full ownership of this successful joint venture will enable us to provide our U.K. pharmaceutical customers with a broader and more integrated range of flexible pre-wholesaling and contract logistics solutions, while further building on our investment in the Alloga network across Europe," stated Ornella Barra, chief executive, wholesale and brands, Alliance Boots. 
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FDA to host public hearing regarding the implementation of GDUFA

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities. Requests to make oral presentations at the hearing are due Sept. 3. 
 
The five draft guidance documents include: 
 
  • Abbreviated new drug application submissions, including content and format of ANDAs;
  • Guidelines on the refusal to receive submissions for lack of proper justification of impurity limits;
  • Amendments and easily correctable deficiencies under GDUFA;
  • Prior approval supplements under GDUFA; and
  • Controlled correspondence related to generic drug development. 
 
Another purpose of the hearing will be to solicit feedback on issues that may arise in FDA’s consideration of 180-day exclusivity provided for in section 505(j)(5)(B)(iv) of the FD&C Act, the agency announced. "Timing of ANDA approval is directly affected by an applicant’s eligibility for 180-day exclusivity, and thus FDA’s consideration of any issues related to 180-day exclusivity is a component of approval actions," the agency stated. "FDA decisions regarding 180-day exclusivity are fact-specific, and the facts that have the potential to determine eligibility for exclusivity may shift up to the time when an ANDA that is eligible for 180-day exclusivity, or another ANDA referencing the same listed drug, is ready for approval."
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