LYRICA

FDA-2026-P-2430 · 6 docket documents

Hyman, Phelps & McNamara, P.C., on behalf of its client, filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Pregabalin Tablets in 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg strengths suitable for submission in an ANDA, w

FDA-2025-P-1135 · 7 docket documents

Lachman Consulting Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting that the FDA declare Pregabalin Orally Disintegrating Tablets in strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg suitable for submission as an ANDA, with LYRICA Capsules (NDA

FDA-2012-P-0583 · 6 docket documents

Pfizer Inc filed this citizen petition under 21 U.S.C. 351 and 355 requesting that the FDA Commissioner refuse to approve any abbreviated new drug applications referencing Pfizer's Lyrica (pregabalin) that contain a minimum level specification for R-isomer impurity, refuse to accept amendments chang

FDA-2012-P-0545 · 3 docket documents

Pfizer Inc filed this citizen petition under 21 U.S.C. 355(j) requesting that FDA refuse to approve any abbreviated new drug applications referencing Lyrica (pregabalin) that contain a "not less than" minimum specification for R-isomer impurity, and refuse to accept amendments to such specifications

FDA-2010-P-0087 · 4 docket documents

Sandoz Inc. filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving any ANDA for generic pregabalin capsules if the proposed labeling omits or carves out either the seizure indication or pain indications of LYRICA, argu