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On Thursday, the FDA proposed removing oral phenylephrine from the list of approved active ingredients for over-the-counter (OTC) nasal decongestants, citing concerns over its effectiveness.
After reviewing available data, the agency determined that oral phenylephrine does not provide the expected relief for nasal congestion despite its widespread use in many OTC drug products.
This proposed order is based solely on concerns about effectiveness, not safety, and will not impact nasal spray products containing phenylephrine.
Currently, oral phenylephrine is found in various OTC products, either as a standalone ingredient or in combination with other drugs such as acetaminophen or dextromethorphan.
New York Times adds that the ingredient has been used alone and in combination with other painkillers, cough suppressants, and agents meant to ease cold and flu symptoms in medications like Kenvue Inc’s Tylenol, Reckitt Benckiser Plc’s Mucinex, and Benadryl.
However, phenylephrine in these combinations does not affect the efficacy of other active ingredients for treating cold or allergy symptoms.
Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research (CDER), emphasized that the agency's role is to ensure drugs are both safe and effective.
She noted that, after a comprehensive review of historical and recent clinical data, it became clear that oral phenylephrine does not meet the effectiveness criteria for nasal decongestion.
This conclusion is supported by the FDA's advisory committee, which last year unanimously agreed that the current scientific data does not support oral phenylephrine's use as a nasal decongestant.
In addition to the review, the FDA held a meeting of the Nonprescription Drug Advisory Committee to evaluate new evidence regarding phenylephrine's effectiveness.
Based on the committee's recommendations and additional data, the agency is moving forward with this proposed order. While the FDA has issued a proposal, it has yet to issue a final order, which would determine the future availability of products containing oral phenylephrine as a nasal decongestant.
The FDA is seeking public comments on this proposed change and will consider feedback before issuing a final decision.
If the FDA concludes that oral phenylephrine is ineffective, manufacturers must reform or remove their products from the market.
Photo via Shutterstock
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Consumer health company Kenvue Inc. reported third-quarter sales of $3.89 billion, down 0.4% year-over-year (up 0.9% organically), slightly below the consensus of $3.93 billion.
Kenvue’s some of the iconic brands include Aveeno, BAND-AID Brand, Johnson’s, Listerine, Neutrogena, and Tylenol.
Value realization was driven by a combination of carry-over pricing and price actions taken this year. The volume decline was driven primarily by Skin Health and Beauty and Self Care, partially offset by growth in Essential Health.
Adjusted gross profit margin expanded 130 basis points to 60.7% from 59.4% in the prior year, reflecting productivity gains attributable to global supply chain efficiency initiatives and benefits from value realization.
Third quarter adjusted operating income margin was 22.1% vs 23.3% in the prior year.
The self-care segment recorded $1.63 billion in net sales, up 0.7% year over year. The skin health and beauty segment recorded a 4.2% drop in second-quarter net sales to $1.07 billion. Essential Health segment sales increased around 1.6% to $1.20 billion.
“During the third quarter, we continued to drive strong productivity and realize efficiency benefits from Our Vue Forward, which we are reinvesting behind our iconic brands to unleash the full potential of our business and fulfill our commitment to create long-term shareholder value,” said Thibaut Mongon, Chief Executive Officer. “This reinvestment is enabling us to continue to drive share gains in Self Care, deliver broad-based growth across the Essential Health categories, and build the right foundation in Skin Health and Beauty, where we are seeing early signs of recovery.
Guidance: Kenvue expects 2024 net sales growth and organic growth toward the low end of its outlook of 1.0%-3.0% and 2.0%-4.0%, respectively.
The consumer health giant reaffirms 2024 adjusted EPS of $1.10-$1.20 versus consensus of $1.14
Price Action: KVUE stock is up 3.44% at $23.28 at the last check on Thursday.
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Photo via Shutterstock
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
For the quarter ended September 2024, Kenvue (KVUE) reported revenue of $3.9 billion, down 0.4% over the same period last year. EPS came in at $0.28, compared to $0.31 in the year-ago quarter.
The reported revenue compares to the Zacks Consensus Estimate of $3.92 billion, representing a surprise of -0.56%. The company delivered an EPS surprise of +3.70%, with the consensus EPS estimate being $0.27.
While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance.
Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance.
Here is how Kenvue performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts:
View all Key Company Metrics for Kenvue here>>>
Shares of Kenvue have returned +4.5% over the past month versus the Zacks S&P 500 composite's +3.2% change. The stock currently has a Zacks Rank #4 (Sell), indicating that it could underperform the broader market in the near term.
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