FDA gives nod, tentative OK to Glenmark’s 3 generics

Glenmark is starting 2021 with three generic approvals. The Mahwah, N.J.-based company has received approval or tentative approval for generics of Otezla, Cialis, Horizant. 

Glenmark has received tentative approval for apremilast tablets in dosage strengths of 10 mg, 20 mg and 30 mg. The medication is the generic of Amgen’s Otezla tablets, indicated to treat moderate-to-severe plaque psoriasis.

Otezla tablets had a market value of approximately $2.7 billion, according to IQVIA data for the 12 months ended November 2020. 

Glenmark's tadalafil tablets were given full approval in dosage strengths of 2.5 mg, 5 mg, 10 mg and 20 mg. Like branded Cialis from Eli Lilly, the generic is indicated to treat impotence or erectile dysfunction. The drug had a market value of approximately $125.5 million for the 12 months ended November 2020, according to IQVIA.

The FDA gave tentative approval to Glenmark for gabapentin enacarbil extended-release tablets, in dosage strengths of 300 mg and 600 mg, a generic of Arbor's Horizant extended-release tablets. The drug is used to treat adults with moderate to severe primary restless leg syndrome, as well as to manage pain from damaged nerves that follows healing of shingles in adults. Horizant had a market value of roughly $99.5 million for the year ended November 2020, per IQVIA data.