FDA grants clearance of market, sale of new allergy-friendly latex condom
WILMINGTON, Del. Vystar and Alatech Healthcare on Friday announced that the Food and Drug Administration granted 510(k) clearance to market and sell Alatech’s Envy condom manufactured with Vytex Natural Rubber Latex.
The Envy condom will be the first consumer medical product available in the U.S. made from Vystar’s patented Vytex NRL, which has less than 2 micrograms/dm2, virtually undetectable levels, of the antigenic proteins that can cause an allergic response, while retaining and improving upon all the desirable qualities of latex.
The Envy condom will carry labeling that will reflect the lowest antigenic protein content currently available in a natural rubber latex medical device in the U.S. Natural rubber latex contains more than 200 proteins, similar to other natural plant materials, of which 13 are known allergens. The Vytex NRL process was created to significantly reduce these known proteins. Vystar’s business model is to assist all manufacturers in marketing the Vytex component of their products.
Alatech will market and sell the Envy NRL condom to retailers and through other distribution channels, and expects the product to be available to consumers in the coming months.
Perrigo reports growth in Q3
ALLEGAN, Mich. Perrigo on Thursday reported revenues of $505.9 million on 5% growth for its third quarter ended March 28, including $419.1 million across its consumer healthcare division, representing a 12% increase.
“In this quarter, the over-the-counter category [as a whole] fell 3% versus third quarter last year and the national brand category fell more than 7%, while Perrigo Consumer Healthcare grew 12%,” commented Joe Papa, Perrigo chairman and CEO. “We were able to achieve this growth rate despite the fact that we are comparing the results to the launches of omeprazole [Prilosec OTC] and cetirizine [Zyrtec] at this time last year. More consumers than ever are realizing the value that store brands have to offer.”
On Feb. 20, Perrigo announced that it began shipping its combination sleep aid-analgesic ibuprofen and diphenhydramine citrate tablets, 200/38-mg. The product is comparable with Wyeth Consumer Healthcare’s Advil PM tablets, 200/38-mg, which generated approximately $71 million in brand sales for the 12 months ended Dec. 21, Perrigo reported.
CDC confirms 896 swine flu cases
ATLANTA The number of confirmed H1N1 cases in the United States climbed to 896 cases, with two deaths, the Centers for Disease Control and Prevention announced Thursday morning.
“The ongoing outbreak of novel influenza A (H1N1) continues to expand in the United States,” the agency stated. “CDC expects that more cases, more hospitalizations and more deaths from this outbreak will occur over the coming days and weeks.”
CDC has issued guidance for health care providers on the use of antiviral medications during the current outbreak. The priority use for influenza antiviral drugs is to treat severe influenza illness and people who are at high risk of serious influenza-related conditions.
And CDC has developed a PCR diagnostic test kit to detect this novel H1N1 virus and has now distributed test kits to all states in the U.S. and Puerto Rico. This increase in testing capacity is likely to result in an increase in the number of reported confirmed cases in this country, which should provide a more accurate picture of the burden of disease in the United States.