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One factor is that by far the biggest profits are to be had in the US.

Maybe you can get approved in Australia or Sweden, but that will pay negligible sums compared to getting into the US market.

Could try for market pressure - for example, that male birth control being developed in India we keep hearing about. I bet it'll get approved here faster than normal because of how desired it is.

Related anecdote: to this day, in Japan access to the Pill remains limited because of vague "safety" concerns, despite decades of use. However, when Viagra appeared, it was approved in months...

Well, they do have a shrinking population problem...

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