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This regulatory strategy leverages bioequivalence studies to expedite approval, positioning Gelteq’s gel as an alternative to traditional oral delivery forms. In the pharmaceutical segment, Gelteq advances its lead product — a gel-based pain management therapy — through the US Food and Drug Administration (FDA)’s 505(b)(2) pathway.
Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). Generic medicines must go through bioequivalence studies to show that generic medicine produces the same amount of active drug in the body. Alternative progesterone-only methods of contraception .
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