Cipla receives final approval for generic version of Biogen IDEC Inc.’s Tecfidera

▴ Cipla receives final approval for generic version of Biogen IDEC Inc.’s Tecfidera
Cipla Limited today announced that it has received final approval for its ANDA for Dimethyl Fumarate Capsules

Cipla Limited today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Dimethyl Fumarate DR Capsules 120mg, 240mg, and 120mg/240mg Starter Pak from the United States Food and Drug Administration (US FDA).

Cipla’s Dimethyl Fumarate DR Caps 120mg, 240mg, and 120mg/240mg Starter Pak 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 be providing Co-Pay Assistance.

Tags : #LatestPharmaNewsSep25 #LatestCiplaNewsSep25 #ANDAapproval #DimethylFumarateDRCapsules #GenericversionofTecfidera #Treatmentformultiplesclerosis

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Scars That Never Heal: The Painful Reality of Female Genital MutilationFebruary 06, 2025
Maharashtra’s Healthcare Betrayal: Why Are Crucial Funds Going Unused?February 06, 2025
1vision, 1 mission: Avaada Foundation’s CSR initiatives are powering communities and delivering sustainable progress across 5 key focus areasFebruary 06, 2025
Top 5 Technology Brands that are Transforming the Cancer Care Journeys for Hospitals and PatientsFebruary 06, 2025
Women's Wellness brand NUA Raises Rs 35 Crore in Pre-Series C led by Mirabilis Investment TrustFebruary 06, 2025
8 Effective Ways to Minimize Postpartum ComplicationsFebruary 06, 2025
Does Where You Live Decide Your Fate? The Urban-Rural Breast Cancer Divide in IndiaFebruary 06, 2025
Nepal leads the world with largest pictorial health warnings on all tobacco productsFebruary 05, 2025
Fleetguard Filters Private Limited Recognized for Excellence in CSR at Navabharat’s 4th CSR ConclaveFebruary 05, 2025
Six new regions of the Russian Federation are set to connect to Moscow's AI medical services platform, MosMedAIFebruary 04, 2025
Six new regions of the Russian Federation are set to connect to Moscow's AI medical services platform, MosMedAIFebruary 04, 2025
Ashok Leyland Reinforces ESG Commitment, Ranked No. 1 Globally in Sustainalytics’ RatingsFebruary 04, 2025
Calcium Supplements: Do You Really Need Them?February 04, 2025
Digital Diagnostics Doubles Its Foreign Publication Count in 2024February 04, 2025
World Cancer Day quotesFebruary 04, 2025
India can take a big leap in Cancer Care with Improved access to treatment and People-centered Approach: ExpertsFebruary 04, 2025
Lilly India appoints Winselow Tucker as the President and General ManagerFebruary 04, 2025
Driving Excellence in Clinical Research: ISCR's 18th Annual Conference Highlights Innovation, Technology, and Patient-CentricityFebruary 04, 2025
Southern Cross University introduces Access25 initiative to make international education more accessible to Indian studentsFebruary 04, 2025
Why Millions Suffer from Ineffective Treatments And the New Science That Can Save ThemFebruary 04, 2025