An ANDA that is not approved usually contains minor deficiencies and/or major deficiencies. Once a minor deficiency letter has been issued in response to the filed ANDA, the corresponding generic company must respond to the deficiencies pointed out in the letter. Once this response id sent back to the agency for a review, the FDA has a 60-day period to respond. If a major deficiency letter has been issued, the FDA has a 180-day review clock to review the company’s response to the major deficiency letter issued according to 21 CFR 314.101. If the FDA refuses to file the application, the generic company can request an informal meeting with the agency to discuss the agency’s decision not to file within 30 days of the date of the FDA’s refusal notification.
If the FDA persists in its decision to refuse to file the application, the generic company may withdraw the ANDA, make amendments to the original ANDA to correct the deficiencies, or take no action in which case the FDA will refuse to receive the ANDA according to the 21 CFR Section 314.101(3). Within 180 days after the date application was filed in addition to any review times for minor or major deficiencies, the FDA will either approve or disapprove the ANDA. When the FDA disapproves the ANDA, the generic company will have an opportunity for a hearing
regarding a not approvable letter according to 21 CFR Section 314.101, Applications for FDA Approval to Market a New Drug.
