Teligent Surprised By Orphan Generic Setback

FDA Wants More Information On Complex Generic

03 Jan 2020

• By Aidan Fry

US niche generics specialist Teligent has expressed surprise at a complete response letter issued by the FDA over an application for a generic of an orphan drug.

Oliver_Twist — Teligent has suffered a setback in its bid to bring a generic of an orphan drug to the US market • Source: Shutterstock

Teligent has been surprised by a complete response letter issued over an abbreviated new drug application for its first complex drug indicated for an orphan disease population. “In the letter, the US Food and Drug Administration requested further information and raw data to support the ANDA,” revealed the US niche generics specialist, which is working on the orphan generic with an undisclosed development partner.

“This latest response from the FDA is unexpected given the time and opportunity that the FDA had to request the information during the ANDA’s active review,” commented Teligent’s president and...

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