Article · Health news

FDA approves generic hormone therapy patch

Health news Published · sources checked

The US FDA approved the first generic version of the Climara Pro once-weekly patch, which combines estradiol and levonorgestrel, on 20 October 2026.

Key points

  • The US FDA approved the first generic of Climara Pro on 20 October 2026.
  • Climara Pro is a once-weekly patch containing estradiol and levonorgestrel for women with an intact uterus.
  • The FDA describes the generic as therapeutically equivalent to the brand product.
  • This is a US decision; UK availability is decided separately.

What was announced

On 20 October 2026 the US Food and Drug Administration (FDA) approved the first generic version of Climara Pro.

Climara Pro is a transdermal patch, worn for a week at a time, that contains estradiol and levonorgestrel and is for women with an intact uterus.

The FDA describes the generic as therapeutically equivalent to the brand product.

What it means

The FDA says the progestogen in the patch is there to reduce the risk of endometrial hyperplasia, which can occur with oestrogen alone.

The agency presented the approval as a way to widen access to medicines.

This is a US decision; availability in the UK is decided separately by the MHRA and NICE.

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