Aurobindo receives FDA OK for 2 generics

Aurobindo has received permission from the Food and Drug Administration for two generics.

The company has received the FDA nod for topiramate capsules, 15 mg and 25 mg, which is the generic of Janssen’s Topamax.

[Read more: Aurobindo receives FDA approval for 3 generics]

Topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients aged 2 years old and older; as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients aged 2 years old and older; and for the preventive treatment of migraine in patients aged 12 years old and older. 

Topiramate capsules have a market value of roughly $76.2 million for the 12 months ending July 2023, per IQVIA.

Aurobindo also obtained FDA approval for deferasirox tablets, 90 mg, 180 mg and 360 mg, which is the generic of Novartis’s Jadenu.

Deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional iron overload); and for the treatment of chronic iron overload in non-transfusion-dependent thalassemia syndromes.

[Read more: Aurobindo obtains FDA OK for 2 generics]

Deferasirox tablets have an estimated market size of $46.6 million for the 12 months ending July 2023,  per IQVIA.