Lupin receives FDA approval for generic Lodosyn tablets and Kapvay Extended-Release tablets

Pharma Major Lupin has announced that it has received final approval for its Carbidopa Tablets, 25 mg and Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg from the United States Food and Drug Administration (FDA) to market a generic version of Aton Pharma, Inc.’s Lodosyn Tablets, 25 mg and generic version of Concordia Pharmaceuticals Inc.’s Kapvay Extended-Release Tablets 0.1 mg respectively.

Lupin’s Carbidopa Tablets, 25 mg is the AB rated generic equivalent of Aton Pharma, Inc.’s Lodosyn Tablets, 25 mg. It is indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.

Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg is the AB rated generic equivalent of Concordia Pharmaceuticals Inc.’s Kapvay® Extended-Release Tablets 0.1 mg. It is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.

Carbidopa Tablets, 25 mg had annual sales of approximately USD 21.9 million in the US (IMS MAT June 2017).

Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg had annual sales of approximately USD 66 million in the US. (IMS MAT Jun 2017).