FDA approves 3 Lupin generics

SILVER SPRING, Md. — Generic manufacturer Lupin has had a busy week. The company has received approval from the Food and Drug Administration for three generics, including generics of Axiron (testosterone topical solution, 30 mg per actuation), Lodosyn (carbidopa) tablets and Kapvay (clonidine hydrochloride) extended-release tablets.

Lupin’s Axiron generic is indicated for replacement therapy in males for conditions associated with deficiency or absence of endogenous testosterone. It had U.S. sales of roughly $244.2 million for the 12 months ended June 2017, according to QuintilesIMS data.

Lupin’s generic of Kapvay will be available in a 0.1-mg dosage strength and is indicated as a monotherapy or adjunctive therapy for attention deficit hyperactivity disorder. The drug had U.S. sales of $66 million for the 12 months ended June 2017l, according to QuintilesIMS.

The company’s Lodosyn generic will be available in 25-mg tablets and is indicated to treat symptoms of idiopathic Parkinson’s disease, postencephalitic parkinsonism, and symptomatic parkinsonism. The drug had annual sales of roughly $21.9 million for the 12 months ended Jun 2017, according to QuintilesIMS data.