A US based mid-sized company held an originator product authorised for a rare indication. This product was facing market pressure due to generic competition from products with the same active ingredient but authorised for a more prevalent indication. Clinigen assisted in addressing generic competition by securing a second indication for their originator product. This was achieved through strategic regulatory support, including FDA consultation, obtaining a paediatric study waiver, and submitting an efficacy supplement using existing data. The approach allowed the company to differentiate their product in the market without the need for new clinical trials, enhancing both market position and cost efficiency.
Read the case study to learn how Clinigen’s expertise ensured a successful and timely approval process, providing significant business value to the client.
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