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Aurobindo Pharma Receives USFDA Approval for Perampanel Tablets
Aurobindo Pharma received final approval from the US drug regulator to make and sell Perampanel tablets.
The tablets will come in six strengths, from 2 mg to 12 mg.
They are equivalent to a medicine called Fycompa.
The medicine is used to help treat certain kinds of seizures in children and adults.
One use is for patients aged four and older, and another is for patients aged 12 and older.
Aurobindo says the US market was estimated at US$67 million for the year ending August 2026.
The tablets will be made at a facility run by APL Healthcare.
The company plans to launch them in the third quarter of fiscal year 2027.
Aurobindo Pharma announced on October 3, 2026, that it received final USFDA approval to manufacture and market Perampanel tablets.
The approval covers six strengths, from 2 mg to 12 mg, equivalent to Catalyst Pharmaceuticals’ Fycompa tablets.
The tablets are indicated for specified seizure treatments in patients aged four and older, and as adjunctive therapy for another seizure type in patients aged 12 and older.
IQVIA estimated the US market at US$67 million, or approximately ₹558 crore, for the 12 months ending August 2026.
Manufacturing is planned at APL Healthcare’s Unit-IV, with launch scheduled for the third quarter of fiscal year 2027; Aurobindo reported 599 USFDA ANDA approvals.
- Who
- Aurobindo Pharma received the approval from the US Food and Drug Administration.
- What
- Final approval to manufacture and market Perampanel tablets in six strengths.
- Where
- For the US market; manufacturing is planned at Unit-IV of APL Healthcare.
- When
- Announced October 3, 2026; launch planned for the third quarter of fiscal year 2027.
- Why
- The tablets are indicated for specified seizure treatments.
Key facts
- Approved strengths
- 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg.
- Reference product
- Fycompa tablets from Catalyst Pharmaceuticals; the tablets are described as bioequivalent and therapeutically equivalent.
- Estimated market
- US$67 million (approximately ₹558 crore) for the 12 months ending August 2026, according to IQVIA MAT data.
- Manufacturing site
- Unit-IV of APL Healthcare, a wholly-owned subsidiary of Aurobindo Pharma.
- Planned launch
- Third quarter of fiscal year 2027.
- ANDA approvals
- Aurobindo reported 599 USFDA approvals: 574 final and 25 tentative.
Sources
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