Cipla gets US approval for cancer drug, Glenmark for oral contraceptive

Two Indian pharmaceutical companies, Cipla and Glenmark, said they received approval from the US Food and Drug Administration for new drugs.

While Cipla got the nod for a drug used to treat a type of blood cancer, Glenmark was approved to sell an oral contraceptive.

Cipla got approval to sell a generic version of Otsuka America Pharmaceutical Inc.’s Dacogen. It is used to treat myelodysplastic syndromes (MDS), which are a group of cancers in which immature blood cells in the bone marrow do not mature and therefore do not become healthy blood cells.

Early on there are typically no symptoms. Later symptoms may include feeling tired, shortness of breath, easy bleeding, or frequent infections.

It has sales of approximately $180M in the US.

The product is available for shipping immediately, Cipla said.

Glenmark was approved to sell a generic version of the oral contraceptive Loestrin of Allergan Pharmaceuticals International.

The branded version of the drug has annual sales of approximately $96.7 million.

With this, Glenmark has 128 products authorized for distribution in the U.S. and 59 pending approval with the U.S. FDA.