Dr Reddy's Gets CDSCO Panel Nod to Market Sumatriptan Nasal Spray to treat acute migraine attacks
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization(CDSCO) has granted approval to drug major Dr. Reddy's Laboratories to manufacture and market Sumatriptan Nasal Spray 10mg/0.1ml for the acute treatment of migraine attacks with or without aura.
This came after the firm presented the proposal for manufacturing and marketing of Sumatriptan Nasal Spray 10 mg/0.1 ml for the indication “for the acute treatment of migraine attacks with or without aura along with results of bioequivalence (BE) Study and multicentric efficacy study conducted in the USA.
In addition to this, the firm also requested a local clinical trial waiver.
Sumatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in the head, stopping pain signals from being sent to the brain, and blocking the release of certain natural substances that cause pain, nausea, and other symptoms of migraine.
Sumatriptan is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea or sensitivity to sound and light). Sumatriptan is in a class of medications called selective serotonin receptor
At the recent SEC meeting for Neurology and Psychiatry held on 17th May 2023, the expert panel reviewed the proposal for manufacturing and marketing of Sumatriptan Nasal Spray 10 mg/0.1 ml for the indication “for the acute treatment of migraine attacks with or without aura along with results of BE Study and multicentric efficacy study conducted in the USA.
The committee noted that the Sumatriptan Nasal Spray 5mg and 20mg per actuation are already approved in India by CDSCO. Furthermore, the Sumatriptan Nasal Spray 10mg/0.1ml of Dr. Reddy’s Lab is approved by USFDA.
After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of Sumatriptan Nasal Spray 10mg/0.1ml for the indication “for the acute treatment of migraine attacks with or without aura”.
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