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Cipla gains after USFDA approval for multiple sclerosis drug

·1-min read

The drug major announced that it has received final approval for its abbreviated new drug application (ANDA) for Dimethyl Fumarate DR capsules 120mg, 240mg and 120mg/240 mg starter pak from the United States Food and Drug Administration (US FDA).

The drug is AB-rated generic therapeutic equivalent version of Biogen IDEC Inc.'s Tecfidera. It is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

According to IQVIA (IMS Health), Tecfidera had US sales of approximately $3.8 billion for the 12-month period ending July 2020. The product is available for shipping immediately. Cipla will providing co-pay assistance.

Cipla is a global pharmaceutical company focused on complex generics, and deepening its portfolio in the markets of India, South Africa, North America, and key regulated and emerging markets.

The company's net profit rose 21% to Rs 578 crore on 9% increase in total revenue from operations to Rs 4,346 crore in Q1 FY21 over Q1 FY20.



Source: Capitalmarket.com