PROGRAF

FDA-2021-P-0083

On January 14, 2021, Hyman, Phelps & McNamara PC filed a suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA declare Tacrolimus Capsules in 0.25 mg, 0.75 mg, 2 mg, and 3 mg strengths su

FDA-2021-P-0083

Hyman, Phelps & McNamara PC filed this suitability petition regarding tacrolimus capsules, requesting FDA guidance on the appropriateness of an immediate-release tacrolimus capsule formulation for regulatory approval. The petition addresses dosing, administration, warnings, and clinical consideratio

FDA-2021-P-0083

Hyman, Phelps & McNamara PC filed a suitability petition regarding PROGRAF (tacrolimus), an immunosuppressant drug approved under NDA for prophylaxis of organ rejection in kidney, liver, and heart transplant patients. The petition requests guidance on the appropriateness and regulatory pathway for d

FDA-2021-P-0083

The provided document is an FDA Orange Book database printout showing approved drug products for tacrolimus (Prograf) in capsule form at three strengths (0.5 mg, 1 mg, and 5 mg) under NDA 050708, with orphan drug exclusivity expiring May 24, 2025. The document does not contain information about a ci

FDA-2013-P-0767

Ascend Laboratories, LLC submitted this citizen petition on June 13, 2013, requesting that the FDA determine the suitability of Tacrolimus Oral Suspension as an additional dosage form to NDA 050708 for PROGRAF (tacrolimus), which is currently approved only as capsules and injection solution for orga

FDA-2007-P-0111

Astellas Pharma US, Inc., the NDA holder for Prograf (tacrolimus), filed this petition under section 505(b) and (j) of the FDCA requesting that the FDA require bioequivalence studies in transplant patients for orally administered narrow therapeutic index immunosuppressants, mandate specific labeling