Zydus Cadila has got a tentative nod from the USFDA to market epilepsy treatment tablets.
Mysuru: Zydus Cadila on June 14 announced that it has received a tentative approval from the United States Food and Drug Administration (USFDA) to market Brivaracetam tablets that is used for the treatment of epilepsy.
The approval has been given to market tablets in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.
The pharmaceutical company Zydus Cadila is a part of the Cadila group, that is headquartered in Ahmedabad, Gujarat. This drug Brivaracetam is used to treat epilepsy. The group has 319 approvals since the commencement of the filing process in the financial year 2003-04.
Zydus Cadila has said that the drug will be manufactured at its manufacturing facility at Ahmedabad.
Other drugs used in the treatment of epilepsy are sodium valproate, acetazolamide, clonazepam, votubia among others. The USFDA is a federal agency that is a part of United States Department of Health and Human Services, wields its authority for inspection of facilities in foreign countries. The organisation is also responsible for the protection of public health by ensuring safety, efficacy and security of human and veterinary drugs, biological products and vaccines developed and marketed in foreign countries.
Without approval by the USFDA, pharmaceutical companies cannot market and sell drugs in the open pharmaceutical market.