Wednesday, 19 September 2018

USFDA gives nod to Jubilant’s generic version of Symmetrel

09 February 2018 | News

Generic version of Symmetrel is indicated for the prevention and treatment of infection caused by various strains of influenza A virus

Image Courtesy- slimd.com

Image Courtesy- slimd.com

Drug firm Jubilant Life Sciences announced that its subsidiary has received final approval from the US health regulator for Amantadine Hydrochloride tablets, an anti-viral and anti-Parkinsons drug.

The approved drug, generic version of Symmetrel of Endo, is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus.

 It is also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions.

For Amantadine Hydrochloride tablets (100 mg), Jubilant Pharma Ltd, a material wholly owned subsidiary of the company, has received final approval of abbreviated new drug application (ANDA).

This is the ninth approval received by the company from the USFDA during the current financial year.

As per the company’s statistics, till December 31, 2017, Jubilant Life Sciences had 86 ANDAs for oral solids filed in the US, of which 56 have been approved and 12 injectable filings, of which 10 had been approved.

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