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Bausch Expects US Approval In 2020 Of Preservative-Free OTC Ketotifen Eye Drop

 
• By Eileen Francis

Bausch says it expects US FDA to approve its ANDA for the first preservative-free OTC eye drop for ocular itching associated with allergic conjunctivitis in the second half of 2020. The firm reports its Lumify redness relief drops generated sales of $63m for 2019.

Eye

Bausch Health Companies Inc. expects US approval during the second half of 2020 of its application for the first preservative-free OTC eye drop containing ketotifen for the treatment of itching associated with allergic conjunctivitis.

Bausch submitted to the Food and Drug Administration an abbreviated new drug application for OTC use of preservative-free ketotifen, identified as investigational new drug EM-100, early in 2019 but in...

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• By Malcolm Spicer

Country Life Vitamins launches healthy aging support line as it announces less than half of US consumers in a recent survey were aware of biological processes that affect aging. Groupe Berken and Arctic Biosciences partner to bring to North America herring caviar oil extract in a supplement designed to support optimal health across all life stages.

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• By Malcolm Spicer

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• By Malcolm Spicer

Masdel expects its Original Magic Bag hot or cold compress to catch on as a popular as well as effective product from north of the border.

OTC Wearables: Wild.AI On Amazfit, ObeEnd Weight Management, Cronometer Tracks Water

 
• By Malcolm Spicer

Wild.AI women's health and wellness app available on Zepp’s Amazfit Active; WAT Medical’s app helps users lose weight; and firm Cronometer adds feature to answer users’ most frequent question, "How do I track water?"

More from North America

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 
• By Eileen Francis

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

 
• By Derrick Gingery

US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.

US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

 
• By Malcolm Spicer

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.