FDA: Plan B generic equivalents can be sold without restrictions
SILVER SPRING, Md. — The Food and Drug Administration last week ruled that generic equivalents to Teva Pharmaceutical’s Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser in a letter to the interested parties.
However, generic labeling will spell out indicated use for women 17 years of age and older considering that Teva has exclusivity on the indication for use for women under the age of 17, FDA decided.
"Restrictive labeling and point of sale restrictions of the type requested by Teva would be inconsistent with how exclusivity for specific populations is generally handled for ANDAs in other contexts," wrote FDA’s Kathleen Uhl, acting director of the Office of Generic Drugs at the Center for Drug Evaluation and Research.
"For example, when an innovator’s prescription product is granted exclusivity for a new indication, ANDAs approved for the non-protected conditions of use are not required to bear a statement specifically describing the limitations of the approval or to otherwise restrict the use of the generic drug. Similarly, multiple OTC products lack approval in one or more pediatric populations but no point of sale restrictions apply," she noted. "There is no scientific or regulatory reason to depart from that approach here."
PharmaSupply introduces NeedleBay insulin pen organizer
WEST PALM BEACH, Fla. — Pharma Supply earlier this week launched NeedleBay, a safe and easy method of organizing and dispensing insulin pen needles and medication.
NeedleBay provides a highly visible, unique and simple “proof of use” reminder, which eliminates the risk of missed, or excess injections and associated medications. NeedleBay has been specially designed in consultation with healthcare professionals and those with diabetes, to enable the user to deploy disposable pen needles safely and to avoid the risk of needle pick injuries.
NeedleBay allows the user to prepare in advance needles and medication for up to seven days using the NeedleBay daily modules, which can be preloaded at the beginning of the week. The NeedleBay module is compact and fits easily into a pocket or bag. The NeedleBay product line is available in multiple flexible pack sizes and colors.
NeedleBay will be available to consumers in March 2014 and will be supported with a national print and TV commercial campaign beginning in May 2014.
Tender Corp. highlights After Bite Kids insect bite treatment
LITTLETON, N.H. — Tender Corp. on Friday highlighted its After Bite Kids — an insect bite treatment specifically designed to provide relief to kids — in time for summer care planograms.
The non-stinging cream formula contains natural healing ingredients, such as baking soda, aloe vera and tea tree oil, to soothe and moisturize skin from the itching and swelling of insect bites and stings.
“After Bite is a trusted family favorite,” stated Frank Meyer, chief marketing officer at Tender Corp. “Our kids-specific formula uses Grandma’s home remedy — baking soda — for amplified instant comfort and relief of common insect bites. Parents can trust in our brand and the comfort of After Bite Kids.”