Shilpa Medicare informed the exchanges that the Company has received U.S Food and Drug Administration (USFDA) tentative approval for its ANDA, Pirfenidone Tablets, 267 mg and 801 mg on 30 Jan 2020. The ANDA is filed as 'First to File' submission on NCE -1 date.
Pirfenidone Tablets, 267 mg and 801 mg is a generic equivalent of reference listed drug (RLD) Esbriet Tablets, 267 mg and 801 mg, of Hoffmann La Roche Inc. used in the treatment of idiopathic pulmonary fibrosis as recommended in the label approved by FDA.
According to IQVIA MAT Q2 2019 data, the overall US market for Pirfenidone, 267 mg and 801 mg, strengths is approximately US$ 716.3 Million.
Further, Shilpa also received approval for lenvatinib mesylate capsules for patients with 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 in India.
Shilpa will commercialize 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.
Stock view:
Shilpa Medicare Ltd is currently trading at Rs302.90 up by Rs8.7 or 2.96% from its previous closing of Rs294.20 on the BSE.
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