HEALTH

Greater availability of Plan B to boost sales

BY Michael Johnsen

Sales of OTC female contraceptives ought to be significant in the coming year. Already, the category is up 2.3% to $232.7 million, and that number is expected to go up now that the Food and Drug Administration has approved Teva Women’s Health’s Plan B One-Step (levonorgestrel) without a prescription. This ends mandated placement behind the pharmacy counter, as well as the restriction not to sell the product to a woman younger than 16 years old without a prescription.

(For the full category review, including sales data, click here.)

“The availability of Plan B One-Step in the aisles of retailers nationwide ensures improved access to a product that has been clinically evaluated and is a safe and effective backup birth control method for women of all reproductive ages,” stated Martin Berndt, VP and GM of U.S. Brand Pharmaceuticals for Teva Women’s Health.

Plan B One-Step will be the only emergency contraceptive that actually can be sold in the OTC aisles, however. The FDA this summer granted Teva Women’s Health exclusive marketing rights for three years. Approval of the generic version will not allow the manufacturer to sell the drug to anyone younger than 17 until the three-year exclusivity period ends.

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HEALTH

New FDA regulations bring lubricant introductions

BY Michael Johnsen

Sales of personal lubricants were down 5.2% to $207.5 million in sales for the 52 weeks ended Oct. 6, according to IRI across total U.S. multi-outlets. A big part of that decrease is due to new Food and Drug Administration regulations that require lubricant manufacturers to submit a 501k medical device application for approval.

(For the full category review, including sales data, click here.)

“Everybody needed to become approved as a medical device,” Jim Beghtol, Lil’ Drug Store Products director North American sales consumer products, told DSN. “It definitely hurt the category.”

That may explain the spate of recent lubricant introductions and suggest that the category is primed to recover.

The FDA just last month approved Conceive Plus from Sasmar, which joins Li’l Drug Products’ PreSeed as one of the only fertility-friendly personal lubricants that helps increase a woman’s chances of getting pregnant naturally.

One, a specialty brand of premium condoms in North America, this summer sought to extend its non-traditional line into the personal lubricant space with One Move — a silicone-based lubricant — and One Oasis — a water-based lubricant that is paraben-free.

And Sylk USA this summer launched a personal lubricant marketed as gentle and pH balanced. According to the company, the new personal lubricant not only meets the needs of the young woman, but also the menopausal woman and seniors as the product is touted as adding comfort to those suffering from vaginal dryness associated with certain medications and treatments, including chemotherapy and radiation.

Lil’ Drug Store Products is planning a personal lubricant launch in the spring under its Replens banner. “We’re getting ready to launch our own silicone-based item that will appeal to the older crowd,” Beghtol said. “We’ve got thousands of women who are on our [Replens] mailing list,” he said. “And 76% of Replens users use lubricants. So there’s a real opportunity to help our retail partners capture more of the silicone users and help bring this category back to where it needs to be.”

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HEALTH

Next Choice tops emergency contraceptives

BY Michael Johnsen

PARSIPPANY, N.J. — Actavis last year gained approval for its Next Choice, a generic version of Teva Women’s Health’s Plan B One-Step, that now sits on top in emergency contraceptive sales. For the 52 weeks ended Oct. 6, Next Choice generated $115.2 million fueled by 20.2% growth. Plan B One-Step is ranked No. 2 with $96.4 million in sales, down 10.7%. Earlier this year, the FDA increased access to emergency contraceptives by no longer requiring that they be placed behind the pharmacy counter. However, for now, only Plan B One-Step can be sold to women younger than 17 years without a prescription.

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