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Adalvo announces successful Pivotal BE program for Levonorgestrel + Ethinylestradiol

06 March 2023

We are pleased to announce that we have now completed our Pivotal BE program for Levonorgestrel+Ethinylestradiol film-coated tablets 0.15mg/0.03mg. This product has been developed in collaboration with one of our strategic partners.

Our product has been developed based on the reference brand Microgynon 30 film-coated Tablets, which is used by women to prevent pregnancy.

The INN sold approximately $244mn globally in 2021, having a significant growth potential with Global 3Y CAGR at +4%, according to IQVIA. 

Based on this successful development we will now proceed with dossier filing, which is scheduled for April 2023

We offer an array of women’s health dossiers, and our intention is to assist our partners with the different challenges these mature products may entail.