Zydus gets US FDA final approval for Ivabradine Tablets, 5 mg and 7.5 mg
Ivabradine is indicated to reduce the risk of hospitalisation for worsening heart failure in adult patients with stable,…
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Browsing Tag
US FDA
Navigating the shift from low-cost to highest value
The Draft National Pharmaceuticals Policy 2023 advocates a shift from “exceptional quality at low cost” to “exceptional quality at…
Lupin gets US FDA approval for Dapagliflozin tablets and Pitavastatin tablets
Both the products will be manufactured at Lupin’s Pithampur facility in India
Glenmark gets USFDA nod for Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, 10 mg
The tablets will be distributed in the US by Glenmark Pharmaceuticals US
WHO trivalent recommendations will reshape global flu vaccine market: GlobalData
WHO recently advised a reversion to trivalent (three-strain) influenza vaccines for the 2024 southern hemisphere influenza…
Glenmark Pharma gets ANDA nod for Apremilast Tablets, 10 mg, 20 mg and 30 mg
Apremilast Tablets, 10 mg, 20 mg and 30 mg, is the generic version of Otezla Tablets, 10 mg, 20 mg and 30 mg, of Amgen
Lupin gets tentative nod from US FDA for apalutamide tablets
This product will be manufactured at Lupin’s Pithampur facility in India
US FDA accepts Sun Pharma’s NDA for Deuruxolitinib
Deuruxolitinib is being evaluated for treatment of moderate to severe alopecia areata
Marksans Pharma gets US FDA nod for Esomeprazole Magnesium DR Capsules USP, 20 mg (OTC)
Esomeprazole is used to treat certain stomach and esophagus problems such as acid reflux and ulcer
Delegation from US HHS, US FDA, and local govt officials visit Amneal’s Matoda facility
The delegation included Loyce Pace, the Assistant Secretary for Global Affairs, Genessa Giorgi, US HHS Health Attaché to India, Dr…