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FDA marks GDUFA milestones

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year’s reauthorization of the Prescription Drug User Fee Act, the agency said Tuesday.

The FDA’s Center for Drug Evaluation and Research said its Office of Generic Drugs had finished reviewing more than 30% of backlog applications since the passage of the Generic Drug User Fee Amendments while streamlining the process of hiring new scientific reviewers, project managers, investigators and support staff. The FDA plans to bring on board at least 25% of GDUFA program hires by the beginning of October.

In addition, the agency has put in place other improvements designed to ease communication between it and drug companies during the review process, including more detailed complete-response letters, letters the FDA sends to companies when it has completed reviewing a drug-approval application, but issues remain that preclude final approval.

The amendments were part of an effort to improve the generic drug review system at the FDA, which had long struggled with a backlog of more than 2,000 generic drug applications due to insufficient staffing and funding.


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Yankee Candle launches new Relaxing Rituals line including essential oils

BY Jason Owen

SOUTH DEERFIELD, Mass. — The Yankee Candle Company today announced the launch of its new Relaxing Rituals line. The company says each blend of three different essential oils creates a special fragrance combination designed to soothe the mind, body and soul and provide an easy, relaxing ritual that fits busy lifestyles.

The new line includes warmer oils, reed diffusers, votive candles and tumbler candles in four new scents.

“Living a wellness lifestyle is about taking care of the mind, body and soul so that you can be at your best and relaxation is an essential element of this lifestyle.” said, Hope Margala Klein, executive vice president, brand, innovation and merchandising for The Yankee Candle Company, Inc. “Our new Relaxing Rituals line allows our customers to prepare the perfect fragrance blends that suit them while allowing them to turn down all the noise and unwind.

The four fragrance blends available are:

  • Calm — a blend of vanilla, lavender and sandalwood to feel relaxed;
  • Comfort — a blend of rose, cardamom and cedarwood to feel cozy;
  • Tranquil — a blend of spearmint, water lily and sea salt to feel at peace; and
  • Refresh — a blend of mandarin, sage and eucalyptus to feel awake.

To celebrate the new line, Yankee Candle is hosting a debut party on Saturday, July 13th in its retail stores from 10 a.m. – 4 p.m., offering guests a chance to experience the product, enter special giveaways, and participate in one-day savings offers for the new line.

Relaxing Rituals is available now at more than 557 Yankee Candle retail stores, www.yankeecandle.com and in select specialty retailers.


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One Condoms expands line into personal lubricant space

BY Michael Johnsen

BOSTON — One, a specialty brand of premium condoms in North America, on Tuesday announced the launch of One Move — a deluxe, long-lasting silicone lubricant — and One Oasis — a smooth, water-based lubricant that is paraben-free. 

"The choices [among personal lubricants] are diverse and can be confusing to experienced and new consumers alike," stated Davin Wedel, president of One. "We believe our premium lubricants provide a better choice that maximizes pleasure and quality for consumers." 

In addition to an enhanced pleasure experience, lubricants provide a safer sexual experience between partners. Both One lubricants are compatible with natural rubber latex, polyisoprene, and polyurethane condoms. 

The new One lubricants are available in 100 ml bottles and are priced at $18.99 for One Move and $12.99 for One Oasis. One Move and One Oasis join a lineup of One products, including 11 distinctive styles of condoms and two Deluxe Temptations kits.


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