The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.
The approval allows it to market its products in the country
It’s an AB-rated generic therapeutic version of Durezol
Ibuprofen and Famotidine Tablets is an AB-rated generic therapeutic equivalent version of Horizon Medicines LLC’s Duexis Tablets, 800 mg/26.6 mg
Ibuprofen and Famotidine tablets approved by FDA
The company will engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.
Sumatriptan Injection USP is indicated in adults for acute treatment of migraine with or without aura, and acute treatment of cluster headache
In addition to supporting the ongoing development of the first IND-approved product in clinical trials, the proceeds will also be used to expand the 3D printed drug product pipeline
Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.’s Brovana
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