Conduct post marketing clinical study to generate safety data of Nerivio: CDSCO panel Tells Dr Reddy's Lab
New Delhi: Considering the drug major Dr. Reddys Laboratorie's proposal to import the Nerve Electrical Stimulator (Brand Name: Nerivio) intended for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct post-marketing clinical investigation in order to generate safety and performance data of the device in the Indian population.
This came after Dr.Reddy’s Laboratories presented a proposal for a grant of permission to import the Nerve Electrical Stimulator (Brand Name: Nerivio) intended for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older.
In addition to the above the firm stated that it is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment. This device is new and there is no predicate device approved by the Central Licensing Authority.
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