Shilpa Medicare gets US FDA approval for generic Esbriet tablets

Shilpa Medicare has received US Food and Drug Administration (FDA) approval for pirfenidone tablets. The company received US FDA’s tentative approval for its ANDA, pirfenidone tablets, 267 mg and 801 mg, on January 30. The ANDA is filed as 'First to File' submission on NCE -1 date.

Pirfenidone tablets is a generic equivalent of reference listed drug (RLD) Esbriet tablets of Hoffmann La Roche Inc used in the treatment of idiopathic pulmonary fibrosis.

The annual US market for pirfenidone is approximately US$ 716.3 million, as per the IQVIA MAT Q2 2019 data.

The company also received Central Drugs Standard Control Organization (CDSCO), New Delhi permission for manufacturing and marketing of lenvatinib capsules 4mg and 10mg in India.

Lenvatinib capsules 4mg and 10mg is a generic equivalent of reference product, Lenvima, used in the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer and for the first line treatment of patients with unresectable hepatocellular carcinoma.

Shilpa Medicare will commercialise the product under the brand name Lenshil to become the first Indian company in the country to bring the cheaper version of this drug to Indian cancer patients. Now Indian patients will get access to this breakthrough therapy at an affordable cost and manufactured in India. The presently available brand of lenvatinib mesylate in market is being imported into India.

According to IQVIA MAT Q2 2019 data, the Indian market for lenvatinib capsules 4mg and 10mg is approximately US$ 0.32 million.



Popular posts from this blog

EMA Recommends Extension of Indications for Ramucirumab

Dr. Hootie Warren takes helm of Fred Hutch Global Oncology

Merck announces positive event-free survival data from phase 3 KEYNOTE-522 study of Keytruda to treat triple-negative breast cancer