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US FDA accepts Amneal’s Biologics License Application for Bevacizumab
expresspharma
June 18, 2021
Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA.
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Amneal completes acquisition of Kashiv Specialty Pharmaceuticals
expresspharma
April 06, 2021
Kashiv Specialty Pharmaceuticals is focused on the development of complex generics, innovative drug delivery platforms and novel 505(b)(2) drugs.
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Amneal gets USFDA approval for Norelgestromin and Ethinyl Estradiol Transdermal System
expresspharma
March 01, 2021
The company granted 180 days of exclusivity under FDA Competitive Generic Therapy (CGT) approval pathway.
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Amneal to acquire substantially all of Kashiv Specialty Pharmaceuticals
pharmaceutical-business-review
January 15, 2021
Amneal Pharmaceuticals and Kashiv BioSciences announced they have entered into a definitive agreement under which Amneal Pharmaceuticals LLC, a wholly-owned subsidiary of the Company, will acquire a 98% interest in Kashiv Specialty Pharmaceuticals ...
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Amneal launches Generic Abiraterone Acetate Tablets, following US FDA approval
expresspharma
January 11, 2021
They are indicated for treatment of metastatic prostate cancer.
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Amneal gets US FDA approval for Lidocaine Patch
expresspharma
August 26, 2020
Amneal Pharmaceuticals has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for a generic version of Lidocaine Patch, 5%.
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FDA Announces Alert of Amneal, Impax Epinephrine Auto-Injector Malfunctions
americanpharmaceuticalreview
June 11, 2020
FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present.
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Amneal recalls Metformin Hydrochloride Extended Release Tablets to consumer level
europeanpharmaceuticalreview
June 08, 2020
The voluntary recall of Metformin Hydrochloride Extended Release Tablets, 500 mg and 750 mg is due to unacceptable levels of NDMA impurities.
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Novartis, Amneal, Apotex offer hydroxychloroquine for Covid-19
pharmaceutical-technology
March 24, 2020
Novartis is set to donate up to 130 million doses of generic hydroxychloroquine to help fight the Covid-19 coronavirus infection that led to a global pandemic.
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Amneal to Acquire Majority Interest in AvKARE
americanpharmaceuticalreview
December 17, 2019
Amneal Pharmaceuticals and AvKARE have entered into a definitive agreement under which Amneal will acquire a 65.1% majority interest in AvKARE and its related affiliate doing business ...