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FDA-2024-P-4134 · 11 docket documents

Pharmobedient Consulting, LLC filed this petition for reconsideration requesting FDA approval of a suitability petition to submit an ANDA for Diclofenac Potassium Tablets at 37.5 mg strength, a dose different from the Reference Listed Drug Cataflam at 25 mg and 50 mg strengths. The FDA had denied th

FDA-2024-P-2779 · 12 docket documents

Hyman, Phelps & McNamara, P.C. filed an amendment for a suitability petition regarding diclofenac potassium tablets in three strengths (12.5 mg, 25 mg, and 50 mg), which are indicated for treatment of primary dysmenorrhea, mild to moderate pain, osteoarthritis, and rheumatoid arthritis. The petition

FDA-2023-P-4975 · 8 docket documents

On behalf of a client, the law firm Hyman, Phelps & McNamara, P.C. submitted a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Diclofenac Potassium Oral Solution, 25 mg/5 mL, suitable for consideration in an ANDA, with

FDA-2023-P-4464 · 7 docket documents

Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Diclofenac Potassium Tablets, USP 12.5 mg, seeking a determination of regulatory suitability for the drug product under FDA's abbreviated new drug application (ANDA) pathway.

FDA-2023-P-4659 · 7 docket documents

Hyman, Phelps & McNamara, P.C. submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Diclofenac Potassium Capsules, 12.5 mg, suitable for submission as an ANDA, with the reference listed drug being Assertio Therapeutics

FDA-2023-P-4444 · 7 docket documents

Hyman, Phelps & McNamara, P.C. filed a petition regarding the prescribing information for CATAFLAM, a nonsteroidal anti-inflammatory drug. The petition addresses suitability matters related to the product's labeling and prescribing information requirements.

FDA-2023-P-4282 · 12 docket documents

Pharmobedient Consulting, LLC filed a suitability petition regarding diclofenac potassium, requesting that the FDA determine the suitability of this active pharmaceutical ingredient for use in drug products and establish appropriate regulatory pathways for its approval.

FDA-2023-P-0174 · 6 docket documents

Hyman Phelps and McNamara PC filed a petition requesting that the FDA reconsider the Orange Book suitability status of CATAFLAM tablets in 25 mg and 50 mg strengths. The petition challenges the current regulatory classification of these diclofenac potassium products to determine whether they remain

FDA-2022-P-0052 · 9 docket documents

Pharmobedient Consulting, LLC, on behalf of Amici Pharmaceuticals LLC, filed a petition requesting a suitability determination for diclofenac potassium tablets USP 50 mg to establish reference standards for regulatory purposes under an ANDA submission pathway for generic drug approval.

FDA-2021-P-0509 · 6 docket documents

Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Cataflam, requesting that the FDA consider the drug's inclusion on the Discontinued Drug Product List or make a determination regarding its regulatory status and suitability for continued marketing or approval of generic versions.

FDA-2003-P-0127 · 4 docket documents

The Weinberg Group, Inc. filed a suitability petition requesting that the FDA declare Diclofenac Potassium Capsules 25 mg suitable for submission as an ANDA, referencing the approved but discontinued Cataflam (diclofenac potassium) Tablets 25 mg (NDA 20-142), with the proposed product differing only