Cipla has received final approval for its
Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray, 20 mg from the
United States Food and Drug Administration (USFDA).
Cipla s Sumatriptan Nasal Spray USP, 20 mg is an AB-rated generic therapeutic
equivalent version of GlaxoSmithKline s Imitrex Nasal Spray.
Imitrex Nasal Spray is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for
acute treatment of migraine with or without aura in adults.
According to IQVIA (IMS Health), Imitrex Nasal Spray 20mg and its generic equivalents
had US sales of approximately $53.3M for the 12-month period ending December 2020.
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Many patients are experiencing worsening migraine symptoms during covid-19 pandemic .
Is the coronavirus pandemic and the new normal giving you a headache? You’re not alone. Headache specialists worldwide have reported witnessing an increase in migraines or worsening symptoms during the pandemic. Several factors related to the pandemic, such as increased stress levels, more screen time, changes in routine, are blamed for the rise in the number. Stress is thought to be one of the most common triggers of migraine headache and the COVID-19 pandemic, many people are facing with financial and emotional stress. Once it hits, migraine headaches can last for hours or even days. Unfortunately, there is no cure for migraine. But a number of OTC or prescription medications are available to help ease the migraine symptoms, including severe throbbing headache, nausea, vomiting, and nasal congestion. Now, an Indian company has come up with a new triple-combination drug for the treatment of mig
Granules India announced today that the US Food & Drug Administration (US FDA) has approved its
Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250
mg/250 mg/65 mg (OTC).
It is bioequivalent to the reference listed drug product (RLD), Excedrin Migraine
Tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare. The product would be
manufactured at the company s Hyderabad facility and is expected to be launched shortly.
Acetaminophen, Aspirin and Caffeine Tablets are indicated for the treatment of migraine.
Granules now has a total of 38 ANDA approvals from US FDA (37 Final approvals and 1 tentative
approval)
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