The Conversation (0)
Antares Pharma (NASDAQ:ATRS) today announced that the official minutes from the Type A meeting with the U.S. Food and Drug Administration (FDA or the Agency) held on February 21, 2018 have been received. The Company had previously attended the in-person Type A meeting with the FDA to discuss the Complete Response Letter (CRL) received in connection …
Antares Pharma (NASDAQ:ATRS) today announced that the official minutes from the Type A meeting with the U.S. Food and Drug Administration (FDA or the Agency) held on February 21, 2018 have been received. The Company had previously attended the in-person Type A meeting with the FDA to discuss the Complete Response Letter (CRL) received in connection with the XYOSTED™ New Drug Application (NDA).
As quoted in the press release:
The Company anticipates that the resubmission will include re-analyses of existing data, and address labeling and potential post-approval risk mitigation strategies. The Company anticipates submitting the complete response in the second quarter of this year. Under FDA’s policies, thirty days after FDA’s receipt of the resubmission, the Agency will determine whether the filing constitutes a complete response that addresses all deficiencies in the CRL and, if so, assign a target action date which the Company expects will be within six months of FDA’s receipt of the resubmission.
