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Granules Pharma Gets US FDA Tentative Approval for Generic ADZENYS XR-ODT
Granules Pharmaceuticals Inc has received tentative approval from the US FDA for its generic version of Amphetamine Extended-Release Orally Disintegrating Tablets (ADZENYS XR-ODT), which will be manufactured at the company’s US-based facility in Chantilly, Virginia.
US FDA Tentative Approval | 22/12/2025 | By News Bureau
Lupin Receives Tentative Approval from US FDA for its HIV treatment tablets
Lupin has received tentative US FDA approval for Bictegravir, Emtricitabine and Tenofovir Alafenamide Tablets to treat HIV, bioequivalent to Gilead’s Biktarvy, for adults and paediatric patients over 25 kg.
US FDA Tentative Approval | 25/09/2025 | By Dineshwori
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