US FDA approves Zydus Cadila’s dimethyl fumarate DR capsules

These tablets will be manufactured at the group’s manufacturing facility at the SEZ, Matoda

Zydus Cadila has received final approval from the USFDA to market dimethyl fumarate delayed-release capsules, (US RLD: Tecfidera) in the strengths of 120 mg and 240 mg.

In its approval, the USFDA noted that Zydus was one of the first ANDA applicants to submit a substantially complete ANDA and is, therefore, eligible for 180 days of generic drug exclusivity along with other first ANDA applicants.

The USFDA granted approval following the entry of judgment in favour of Zydus Cadila and other ANDA applicants by the United States District Court for the District of Delaware, holding that the only unexpired patent covering Tecfidera is invalid.

Dimethyl fumarate delayed-release capsules are indicated for the treatment of patients with relapsing forms of multiple sclerosis. These tablets by Zydus Cadila will be manufactured at the group’s manufacturing facility at the SEZ, Matoda.

The group now has 303 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.

dimethyl fumarate DR capsulesMultiple SclerosisTecfideraUS FDAZydus Cadila
Comments (21)
Add Comment
  • gurugram escorts

    It is very important to have good thoughts in mind to write a beautiful post, and your mind seems very clear, that is why you have written such a beautiful post, this post is worthy of praise, the praise of this post will be less.

  • Indore Escorts

    This is a great post. I like this topic. This site has lots of advantages. I found many interesting things on this site. It helps me in many ways. Thanks for posting this again.

  • ishika

    The person who writes a very beautiful post is always of a good heart and whenever I am sitting alone, I spend my time looking at such a good post, you have written a good post, which is as much as you can in your life. Will be appreciated And you keep writing such good posts in your life, I wish you all the best.

  • gurugram call girls

    The person who writes a very beautiful post is always of a good heart and whenever I am sitting alone, I spend my time looking at such a good post, you have written a good post, which is as much as you can in your life. Will be appreciated And you keep writing such good posts in your life, I wish you all the best.

  • kajal sarma

    Your article is very interesting. And you have decorated your art beautifully. It inspires people a lot. If the subject is good, then it is also fun to read and this is what people want nowadays, your post is really interesting. Inspired by you, I too think I should write an article on a fun subject.

  • Java Burn

    Although I don’t usually comment on blogs, your article is convincing enough that I can’t help but to write something. Keep up the great work, Man. Java Burn

  • pihu

    Your article is very interesting. And you have decorated your art beautifully. It inspires people a lot. If the subject is good, then it is also fun to read and this is what people want nowadays, your post is really interesting. Inspired by you, I too think I should write an article on a fun subject.

  • kriti Sharma

    Thank you for sharing excellent information. Your website is so cool. I am impressed by the details that you have on this website. Check the link for more information.

  • Ruby Shah

    Really enjoyed this blog.

  • Bella

    Really Great blog thanks.

  • Rati

    Very nice blog thanks for this blog.

  • sweety spa

    Thanks for this blog i really like it.

  • Shamhitha

    Great content thanks for this blog.

  • Sunshine

    Amazing blog Thanks For Sharing With us.