Teligent, Inc. (NASDAQ:TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced its development partner has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for its first complex drug indicated for an orphan disease population. In the letter, the FDA requested further information and raw data to support the ANDA.
“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. Our development partner has assured us that they have the available data and the ability to respond to the FDA’s request expeditiously. We and our development partner will be in active communication with the FDA to ensure that this delay of a critical drug for patients is as short as possible,” commented Jason Grenfell-Gardner. President and CEO of the Company.