HEALTH

C&D gets FDA clearance for advanced pregnancy test kit, launches new app

BY Michael Johnsen

EWING, N.J. — Church & Dwight on Tuesday announced that the Food and Drug Administration has cleared the First Response Gold Digital Pregnancy Test to determine if a woman is pregnant up to six days before her missed period and with more than 99% accuracy from the day of her expected period. In addition, the First Response Early Result Pregnancy Test, which was previously cleared to determine if a woman is pregnant up to six days before her missed period, also has been FDA-cleared to detect pregnancy with more than 99% accuracy from the day of her expected period. 

In addition to the FDA clearance, First Response also announced the availability of their new, global smartphone app, the First Response Tracker. The new app offers four tools to help women track their reproductive health, including a personalized Period Tracker, Ovulation Tracker, “How Far Along Am I?” Pregnancy Tracker and Due Date Calculator. The First Response Tracker eliminates guesswork by predicting a woman’s next period, calculating her most fertile days, estimating how far along she is once she is pregnant and predicting her due date. The app will be available for free in early April for all iPhone and Android phones, or available for download at www.KnowSooner.com.

The First Response Gold Digital Pregnancy Test has been reformulated to include a new antibody to detect an additional form of the pregnancy hormone (i.e., hCG beta core fragment or hCG βcf) that is present throughout pregnancy. Detection of this additional form of the pregnancy hormone, when combined with optimization to the proprietary First Response Gold Digital Pregnancy algorithm, allows it to be the first at-home digital test cleared by the FDA to detect pregnancy as early as six days before the day of the missed period with more than 99% accuracy from the day of the expected period.

“A pregnancy test with results this early and with this level of accuracy from the day of the expected period helps alleviate a woman’s anxiety and help her make the best choices for herself,” stated Mary Jane Minkin, clinical professor of Obstetrics, Gynecology and Reproductive Sciences at the Yale School of Medicine. “I am excited to see this advancement, as it strongly encourages women to practice a healthier lifestyle sooner in the critical first stages of a baby’s development.”

First Response is now the only pregnancy test brand that can tell a woman that she is pregnant one day sooner than any other at-home pregnancy test, allowing her to initiate prenatal care as close to conception as possible, C&D noted. According to a recent survey conducted by First Response, 85% of women feel that technology that is able to detect pregnancy six days before her missed period is important. Additionally, 92% of women surveyed feel that technology that is 99% accurate from the day of her expected period is a priority. 

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WSJ: Pfizer recruiting for Lipitor OTC actual use study

BY Michael Johnsen

NEW YORK — Pfizer is recruiting for a 1,200-patient actual use study to measure whether or not patients can appropriately self-select treating high cholesterol with the statin Lipitor, the Wall Street Journal reported on Sunday. 

The trial is recruiting patients through more than 35 pharmacies and is expected to be completed by year-end.  

The stumbling block for past statin switch applications has been the actual use study. And Pfizer may be facing an even steeper hill given that recommendations for statin drugs have become more complicated, the WSJ reported.  

If approved for sale over-the-counter, Goldman Sachs estimates that a nonprescription Lipitor could generate more than $1 billion in annual sales. Presently, the best-selling OTC medicine is Pfizer’s Advil, which generated $490.9 million in sales across total U.S. multi-outlet for the 52 weeks ended Dec. 29, according to IRI data. That’s followed by Bayer’s Aleve ($364 million) and Procter & Gamble’s Prilosec OTC ($358.8 million).  

CEO Ian Read shared with the WSJ that Pfizer is putting significant resources behind its over-the-counter effort and that the start of the clinical trial was "an important milestone."

Patients signing up for the trial are given an empty box featuring the proposed OTC labeling. In order to appropriately self-select, the patients must know their baseline level of bad cholesterol. In-store tests will be on hand for those patients who don’t know that number. 

"Among other factors, the study will track what percentage of users comply with directions to get cholesterol levels checked again in six weeks, and whether consumers should continue to take the drug if it is working, or consult with a doctor if it isn’t," the WSJ reported.

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FDA: Plan B generic equivalents can be sold without restrictions

BY Michael Johnsen

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."

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