Browsing Tag
US Food and Drug Administration
333 posts
Zydus Lifesciences wins FDA final approval for Isoproterenol HCL injection
Zydus Lifesciences has secured final approval for Isoproterenol Hydrochloride (HCL) Injection USP, 0.2 mg/mL and 1 mg/5 mL…
Zydus Lifesciences bags FDA final approval for Tavaborole Topical Solution
Zydus Lifesciences has won final approval from the US Food and Drug Administration (FDA) for Tavaborole Topical Solution,…
Narcan nasal spray becomes the first OTC naloxone product approved by the FDA for opioid overdose treatment
Emergent BioSolutions’ Narcan nasal spray is now FDA-approved for over-the-counter use. Find out how this could change the fight against opioid overdoses.
Lupin bags tentative approval for Ocaliva Tablets generic in US
Lupin said that it has been issued tentative approval for Obeticholic Acid Tablets, 5 mg and 10 mg…
Can Lupin’s partnership with Caplin Steriles strengthen its position in the US injectable anesthetic market?
Lupin and Caplin Steriles secure FDA approval for generic Rocuronium Bromide Injection, targeting a $53M US anesthesia market segment.
Glenmark Pharmaceuticals set to begin clinical trial of GRC 54276 in US
Glenmark Pharmaceuticals, through its subsidiary Glenmark Specialty, is set to begin a first-in-human, phase 1/2 clinical study of…
FDA concludes inspection at Lupin Bioresearch Centre in Pune
Lupin said that the US Food and Drug Administration (FDA) has concluded an inspection of the company’s bioresearch…
Zydus Lifesciences gets FDA final approval for Erythromycin Tablets generic
Zydus Lifesciences said that it has secured final approval for Erythromycin Tablets USP, 250 mg and 500 mg…
Can Lupin’s clean FDA inspection at its Vizag API plant boost confidence in its global supply reliability?
Lupin’s Vizag API plant clears US FDA inspection with no observations, strengthening its US supply reliability and regulatory track record.
Zydus Lifesciences gets FDA final approval for Olanzapine tablets
Zydus Lifesciences said that it has secured final approval for Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10mg,…