Is Dydrogesterone banned?

Yes, Dydrogesterone is currently not available in the United States; it was withdrawn from the market for commercial reasons. Likewise, the product was withdrawn from the United Kingdom market in 2008 and the Australian market in 2011 for commercial reasons[1].

Dydrogesterone has been marketed for conditions related to progesterone insufficiency for more than 50 years. The drug's safety and tolerability profile has been established, with an estimated exposure to 113 million patients globally. The use of dydrogesterone is specific to each country's regulatory approval and includes the treatment of threatened or recurrent miscarriage, luteal phase support in infertility and menstrual disorders, endometriosis, and hormone replacement therapy postmenopause. The use of dydrogesterone in pregnancy is not indicated in all countries.

Currently, dydrogesterone is approved in Moldova, Russia, and the Netherlands for treating luteal phase support in IVF, which is an ART treatment.

Dydrogesterone is widely available worldwide. It is marketed in the United Kingdom, India, Ireland, South Africa, and Australia but not in the United States, Canada, or New Zealand. The medication was previously available in the United States but has since been discontinued.

Following the withdrawal of dydrogesterone from the US market for commercial reasons, the FDA independently evaluated relevant literature and data for possible adverse post-marketing events and found no information to indicate that dydrogesterone was withdrawn from sale for safety or effectiveness reasons[2]. A Notice by the Food and Drug Administration on 09/06/2017： The Food and Drug Administration (FDA or Agency) has determined that GYNOREST (dydrogesterone) oral tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow the FDA to approve abbreviated new drug applications (ANDAs) for GYNOREST (dydrogesterone) oral tablets, 5 mg and 10 mg, if all other legal and regulatory requirements are met.

Dydrogesterone is currently not available in the United States; it was withdrawn from the market for commercial reasons. Likewise, the product was withdrawn from the United Kingdom market in 2008 and the Australian market in 2011 for commercial reasons. In the United States, dydrogesterone was registered in 1961, and the license was transferred over the years to several companies. In 1997, the current new drug application owner, Solvay, withdrew the product because the registered indications were no longer commercially viable and/or there were potentially conflicting interest regarding other products of which Solvay was the license holder. For the United Kingdom and Australia, low sales of a comparatively cheap drug and the lack of new and commercially interesting indications motivated the withdrawal from the markets.

However, dydrogesterone is currently licensed for use in more than 100 countries globally, with more than 20 European countries having at least one label for its use in pregnancy. The most common brand names of medication containing dydrogesterone are Duphaston (10 mg tablets) and Femoston (a combination of dydrogesterone and E2 in one tablet in various doses), the latter being used for menopausal hormone treatment.

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