ANI Continues To Spearhead FDA’s CGT Path With Prucalopride Launch

US-Based Firm’s Novitium Pharma Subsidiary Holds 20 CGT Approvals

 
• By Dean Rudge

ANI Pharmaceuticals will compete with a product bringing in annual sales of more than $150m after launching the first generic with 180-day exclusivity via the FDA’s competitive generic therapy pathway.

(Shutterstock)

ANI Pharmaceuticals has championed its “superior R&D capabilities” after launching the first US generic version of Takeda’s Motegrity (prucalopride) tablets.

The US firm’s launch – via its Novitium Pharma subsidiary – of the serotonin-4 receptor agonist for adult chronic idiopathic constipation comes with 180 days of competitive generic therapy...

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