Aurobindo Pharma gets FDA approval for perampanel epilepsy tablets
Aurobindo Pharma just got the go-ahead from the US Food and Drug Administration (FDA) to make and sell Perampanel tablets, used for treating seizures in epilepsy.
These tablets match Catalyst Pharmaceuticals's Fycompa and will be available in several strengths.
Production is set for its APL Healthcare facility, with a US launch planned for Q3 FY27.
Aurobindo launches Adquey, 599 ANDA approvals
Aurobindo also launched Adquey in the US on October 1, a non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor for atopic dermatitis (eczema) in patients as young as two.
Originally discovered by Otsuka Pharmaceutical and licensed to Aurobindo's Acrotech, Adquey is patent-protected until 2036 and targets a $1.3 billion market.
With these moves, Aurobindo now has 599 ANDA approvals from the USFDA, comprising 574 final approvals and 25 tentative approvals, marking a big step forward in its expansion plans.