{
  "id": 11961943,
  "title": "Aurobindo Pharma Gets USFDA Nod For Generic Epilepsy Tablets",
  "url": "https://urgent.news/2026/10/04/aurobindo-pharma-gets-usfda-nod-for-generic-epilepsy-tablets",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-10-04T15:48:47.000Z",
  "source": {
    "name": "Free Press Journal",
    "slug": "free-press-journal",
    "url": "https://www.freepressjournal.in/india/aurobindo-pharma-gets-usfda-nod-for-generic-epilepsy-tablets"
  },
  "original_language": "en",
  "account": "Indian pharmaceutical company Aurobindo Pharma has secured final approval from the US Food and Drug Administration (USFDA) to produce and sell generic epilepsy tablets. The Perampanel tablets, available in multiple strengths, are intended to treat partial-onset seizures of any type in individuals aged four and above, as well as adjunctive therapy for primary generalized tonic-clonic seizures in those aged 12 and older. This new drug is equivalent to Catalyst Pharmaceuticals' reference listed drug Fycompa Tablets, as confirmed in a regulatory filing released on Saturday.\n\nAurobindo Pharma will manufacture the product at Unit-IV of APL Healthcare, their wholly-owned subsidiary, with shipments planned for the third quarter of fiscal year 2027. The market for this approved medication is estimated at USD 67 million over the 12 months leading up to August 2026, based on IQVIA MAT data. Aurobindo Pharma currently holds 599 ANDA (Abbreviated New Drug Application) approvals from the USFDA, with 574 final approvals and 25 provisional approvals.",
  "summary": "New Delhi: Drug firm Aurobindo Pharma has received final approval from the US health regulator to manufacture and market Perampanel tablets in various strengths. The medication is indicated for treating partial-onset seizures with or without secondarily generalised seizures in epilepsy patients aged four years and older, and as adjunctive therapy for primary generalised tonic-clonic seizures in…",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 2,
    "also_reported_by": [
      {
        "outlet": "Free Press Journal",
        "title": "Aurobindo Pharma Receives USFDA Final Approval For Perampanel Tablets, Market Size Estimated At ₹558 Crore",
        "url": "https://urgent.news/2026/10/03/aurobindo-pharma-receives-usfda-final-approval-for-perampanel-tablets",
        "published": "2026-10-03T11:49:24.000Z"
      }
    ]
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}