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Novavax Estrasorb review extension

Executive Summary

FDA extends Novavax Estrasorb July 12 user fee date by three months to Oct. 10. Company expects extension of review period will not delay its planned launch for the first quarter of 2004. Novavax voluntarily withdrew the estrogen replacement cream NDA in April 2002 due to chemistry, manufacturing and controls concerns (1"The Pink Sheet" April 29, 2002, In Brief)...

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Novavax/King Estrasorb approval

Novavax and King will launch topical estrogen emulsion Estrasorb in early 2004 via 125 sales reps, following FDA approval Oct. 9. Hormone therapy approved for vasomotor symptoms; carries class warning from Women's Health Initiative study. Former Lilly exec Ford Lynch tapped to head sales and marketing efforts. NDA was submitted in June 2001 but was withdrawn and resubmitted Sept. 9, 2002. FDA later extended the review time by three months (1"The Pink Sheet" June 30, 2003, In Brief)...

Estrasorb NDA withdrawn

Novavax expects to resubmit NDA for estrogen replacement cream Estrasorb within 90 days following voluntary withdrawal due to chemistry, manufacturing and controls issues. Resubmission will include an assay validation on content uniformity and another degradation study...

Cosmetics Europe Talks Microplastic: ECHA Frustrations, ‘Value Judgments’ And International Trade Uncertainty

The European Chemicals Agency's microplastic restriction proposal received committee backing in 2020 without changes sought by the cosmetics industry, which faces €15bn in projected costs and scarce alternatives at present. It may come down to EU Member States to decide whether the ECHA restriction proposal is proportionate in balancing environmental goals and socio-economic impacts.




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