Alembic obtains FDA nod for 2 generics

Alembic has received the Food and Drug Administration’s nod for two generics.

The first newly approved product is desipramine hydrochloride tablets, in dosage strengths of 10 mg. 25 mg. 50 mg, 75 mg, 100 mg, and 150 mg.

The product is the generic of Validus Pharmaceuticals’ Norpramin tablets. It is indicated for the treatment of depression.

Desipramine hydrochloride tablets had a market value of roughly $7 million for the 12 months ended March 2021, according to IQVIA.

Alembic also received the FDA’s approval for erlotinib tablets in dosage strengths of 25 mg, 100 mg, and 150 mg.

The product is the generic of OSI’s Tarceva tablets. 

It is indicated for the treatment of patients with metastatic non-small cell lung cancer. The tablet in combination with gemcitabine is also indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Erlotinib tablets had a market value of $37 million for the 12 months ended March 2021, according to IQVIA.