Aspen's drug to prevent preterm birth approved by FDA

Reuters

13 September 2019 - The U.S. Food and Drug Administration (FDA) has approved Aspen Pharmacare’s hydroxyprogesterone caproate, which is used to prevent preterm birth in pregnant women, the South African drugmaker’s CEO said on Thursday.

Aspen, which operates in about 56 countries, has said before that it views the United States as presenting targeted growth opportunities for its niche women’s health products such as conjugated estrogens, which is used in menopausal hormone therapy.

Aspen got the FDA abbreviated new drug application approval in early August for a preservative-free, single-dose vial, Chief Executive Stephen Saad said at the pharmaceutical’s annual result presentation.

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Michael Wonder

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Michael Wonder

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