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Colgate Bids To Expand U.S. Toothpaste Lineup Through FDA Rulemaking

 
• By Eileen Francis

Colgate seeks regulatory approval for a version of its Colgate Sensitive Multi-Protection toothpaste in a formulation it already markets internationally. The request made in a citizen petition comes after Colgate’s plan to expand its U.S. toothpaste business failed when FDA did not give approval for Sensitive Pro-Relief.

Colgate-Palmolive Co. seeks regulatory changes that would allow U.S. sales of a toothpaste product the firm markets internationally with an ingredient combination currently not approved by FDA.

Colgate seeks regulatory approval to launch a version of its Colgate Sensitive Multi-Protection toothpaste formulated with a combination of the...

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More from Europe

EU Critical Medicines Act May Include Investigational Products & Mandatory Redistribution Measure

 
• By Neena Brizmohun

The inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.

EU HTA Regulation: Key Gaps Identified In Support For Small Companies And Experts

 
• By Eliza Slawther

A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.

New EU Filings

 
• By Neena Brizmohun

Insulin efsitora alfa, Eli Lilly’s once-weekly, subcutaneous treatment for type 2 diabetes, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

First-Of-A-Kind Nasal Spray For Pain In Children Among 13 New EU Filings

 
• By Neena Brizmohun

Cessatech and Proveca’s investigational, sufentanil/ketamine fixed-dose combination analgesic nasal spray is among the latest drugs that the European Medicines Agency has started to review for potential pan-EU marketing authorization.

More from Geography

EU Critical Medicines Act May Include Investigational Products & Mandatory Redistribution Measure

 
• By Neena Brizmohun

The inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.

EU HTA Regulation: Key Gaps Identified In Support For Small Companies And Experts

 
• By Eliza Slawther

A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 
• By Bridget Silverman

The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.