FDA approves urinary incontinence device as OTC
BROOKFIELD, Wis. — The Food and Drug Administration on Monday cleared InControl Medical's ApexM for over-the-counter sale to treat stress, urge and mixed urinary incontinence in women.
The ApexM provides muscle stimulation through a customizable probe to strengthen the pelvic floor and calms spasms of the bladder muscle, decreasing urgency. ApexM is one of only three devices available for the treatment of urinary incontinence in women. The others — also manufactured by InControl Medical — require prescriptions.
ApexM will retail for a suggested $299, the company reported.
"ApexM should be the first line of treatment for women with urinary incontinence," said Herschel Peddicord, president of InControl Medical. "This product is highly efficacious, simple to use and by far the least expensive treatment available for female urinary incontinence."
Stress incontinence occurs when a woman laughs, sneezes, coughs or exercises. Urge incontinence is characterized by the constant urge to use the bathroom. Mixed incontinence is a combination of both. ApexM treats all three conditions, rendering expensive urodynamic testing to diagnose the type of incontinence unnecessary.
According to the National Association for Continence, up to 40 million women in America have experienced bladder leakage issues at some point in their lives. A study shows almost half of new mothers experience incontinence following normal delivery and about one in six following cesarean section. Up to two-thirds of women who "leak" have never mentioned it to their physicians and just as many do not use any treatment or product to manage their bladder leakage.
New York Senator calls on FDA to ban BMPEA-containing supplements
NEW YORK — Sen. Chuck Schumer, D-N.Y., over the weekend added his voice to the controversy swirling around BMPEA, criticizing the Food and Drug Administration for having not already acted to ban this ingredient from the market, according to a story in The Wall Street Journal published Sunday.
According to the report, Schumer warned that consumers may not know that they are ingesting the stimulant because BMPEA is often listed on federally regulated labels as “Acacia rigidula.” Consumers have “knowingly been deceived by a number of companies that produce dietary supplements,” Schumer said, according to The Wall Street Journal. “It would be bad enough if this were going on without the FDA catching wind of it, but the truth is that the FDA has known about it for two years and done nothing.”
"The Natural Products Association strongly believes that banning products containing BMPEA is an unrealistic way for the FDA to remove them from store shelves, and is a waste of the agency's time and resources," countered Daniel Fabricant, CEO and executive director for the Natural Products Association and former director of the Division of Dietary Supplement Programs at FDA. "The proposed ban is not based in the reality of how food and drug law actually works. The agency has several stronger and quicker tools it can rely on to go after products that it feels pose a threat to consumers, including mandatory recall authority and administrative detention," he said. "What's more, the FDA has the necessary expertise on staff to determine whether BMPEA is dangerous, and if and how it should be removed from the marketplace. While many have questioned whether BMPEA is a legitimate dietary ingredient, that decision is ultimately up to the FDA, and the agency can use its power to take action against companies that have not filed New Dietary Ingredient notifications. The FDA has always had full regulatory authority over dietary supplements, and protecting public health is at the forefront of its mission. NPA supports FDA exercising its full regulatory authority under the law if it finds valid safety concerns with certain products."
The controversy was most recently brought to bear by a Harvard Medical study published last week in the journal Drug Testing and Analysis, in which the lead researcher Pieter Cohen called for the FDA to immediately ban BMPEA or Acacia rigidula, a supplement with weight loss marketing claims.
Hi-Tech Pharmaceuticals buys Mexican OTC manufacturer
NORCROSS, Ga. — Hi-Tech Pharmaceuticals on Monday announced its acquistion of Advanced Pharmaceuticals and Nutritionals, which is headquartered in Guadalajara, Mexico.
Details of the transaction were not disclosed.
"The combination of these two great companies accelerates Hi-Tech's international growth strategy, substantially diversifies our business streams and establishes a durable leadership position in Mexico and the South American Nutritional and OTC marketplace," stated Hi-Tech chairman, president and CEO Jared Wheat. "We believe this strategic transaction will enhance our industry-leading growth profile by expanding market opportunities. APN brings a leading OTC and Nutritional distribution portfolio, Latin America capabilities and a highly experienced management team to support Hi-Tech's continued growth."
APN is one of the larger players within the Latin American OTC and nutritional markets and distributes many leading cough and cold, pain relief, weight management, sports nutrition, nutraceuticals and gastrointestinal treatment brands.
Citing IMS, HI-Tech reported that sales of OTC medicines currently account for approximately 11% of the total global pharmaceutical market (or approximately $87 billion) and Latin American countries command 12% relatively. Latin America is likely to be the fastest growth area for OTC medicine, with a predicted five year CAGR rate of 17%.
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