Replies to post #113080 on Biotech Values

[kaivamei]

TEVA says the "list of questions" is "short", but that does not mean they're easy!

Please correct me if I'm wrong, but my recollection is that in the internal discussions at the FDA, the OGD was the division that has been pressing for standards stricter than the five criteria specified in the response to the citizens petitions. The immunogenicity questions are their domain, and such questions may not by any means be simple for Teva to answer.

From the Teva news release:
"Prior to potential final product approval, the Office of Generic Drugs requires responses to a short list of questions, which Teva intends to respond to in the near future."

[Bio_pete]

MNTA "What was coming? Another TEVA delay"

Thomas, I'd like to say your correct, but the PR doesn't sound like there are major obstacles to gaining approval. I doubt TEVA would spin this with the MNTA lawsuit overhanging.

[jbog]

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.