Browsing Tag
US Food and Drug Administration
333 posts
Caplin Point Laboratories subsidiary gets FDA final approval for Thiamine Hydrochloride Injection
Caplin Point Laboratories said that its subsidiary Caplin Steriles has secured final approval for its abbreviated new drug…
Caplin Point Laboratories gets FDA final approval for Rocuronium Bromide Injection
Caplin Point Laboratories said that Caplin Steriles has been given final approval for Rocuronium Bromide Injection, 10 mg/mL…
Zydus Lifesciences gets FDA final approval for Vigabatrin for Oral Solution
Zydus Lifesciences has bagged final approval for seizures drug Vigabatrin for Oral Solution USP, 500 mg from the…
Reata Pharmaceuticals gets Skyclarys FDA approval for Friedreich’s Ataxia
Reata Pharmaceuticals has secured the approval of the US Food and Drug Administration (FDA) for Skyclarys (omaveloxolone) for…
Zydus Lifesciences gets FDA final approval for Acyclovir Cream
Zydus Lifesciences (formerly Cadila Healthcare) has secured final approval for Acyclovir Cream, 5% from the US Food and…
Zydus Lifesciences bags FDA final approval for Apixaban Tablets
Zydus Lifesciences has bagged final approval from the US Food and Drug Administration (FDA) for Apixaban Tablets, 2.5mg…
Sonofi and Sobi get Altuviiio FDA approval to treat hemophilia A
Sonofi and Sobi have secured the approval of the US Food and Drug Administration (FDA) for their Altuviiio…
Zydus Lifesciences gets FDA final approval for Pitavastatin Tablets
Zydus Lifesciences said that it has bagged final approval for Pitavastatin Tablets, 1mg, 2mg, and 4mg from the…
Moderna, Merck get FDA breakthrough status for mRNA-4157/V940, KEYTRUDA combo in melanoma
Moderna and Merck announced that the investigational personalized mRNA cancer vaccine mRNA-4157/V940 in combination with the latter’s lung…
Zydus Lifesciences gets FDA tentative approval for Gabapentin Tablets
Zydus Lifesciences said that its subsidiary Zydus Pharmaceuticals (USA) has secured tentative approval for once-daily Gabapentin Tablets, 300…