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    Glenmark gets tentative nod from USFDA for generic multiple sclerosis treatment drug

    Synopsis

    These are generic version of Tecfidera Capsules, 120 mg and 240 mg, of Biogen Inc.

    The USFDA also said it has cited similar CGMP violations at two other facilities in the company's manufacturing network.

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    New Delhi: Glenmark Pharmaceuticals on Wednesday said it has received tentative nod from the US health regulator for dimethyl fumarate delayed-release capsules used for treating multiple sclerosis.

    The tentative nod granted by US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc, USA (Glenmark) is for multiple strengths of dimethyl fumarate delayed-release capsules of 120 mg and 240 mg.

    These are generic version of Tecfidera Capsules, 120 mg and 240 mg, of Biogen Inc, Glenmark Pharmaceuticals said in a statement.

    Citing IQVIATM sales data for the 12 month period ending August 2019, the company said Tecfidera Capsules, 120 mg and 240 mg achieved annual sales of approximately $3.7 billion.

    Glenmark's said its current portfolio consists of 161 products authorised for distribution in the US market and 49 abbreviated new drug applications (ANDAs) pending approval with the USFDA.
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    4 Comments on this Story

    Johan Boul33 days ago
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    Tina Perraud216 days ago
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    Karol Doyle378 days ago
    I was diagnosed with multiple sclerosis in 2005, and I was a woman of 40. They put me on Rebif which I took until 2008 and was switched to Copaxone. I had two relapses on Rebif, none on Copaxone. I did notice my balance getting worse, and my memory, as well as muscle spasms.I was placed on Copaxone, it helped me but not very much. My neurologist advised me to try natural treatments and introduced me to Rich Herbal Garden Multiple Sclerosis Disease Herbal formula, I read alot of positive reviews from other patients who used the treatment and i immediately started on the treatment. I had great improvement and relief with this treatment, total decline of symptoms. Great improvement with my Vision problems, co-ordination, balance, muscle, mood etc, I gained back my life with this treatment and can never be thankful enough. Visit Rich Herbal Garden official website w ww .Richherbalgardens .c om I''m 52 now, and have never been healthier.
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