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FDA Approvals - FDA Grants Orphan Drug Status To Reata's RTA 402 For


FDA Grants Orphan Drug Status To Reata's RTA 402 For Treatment Of Pancreatic Cancer (Medical News Today)
Reata Pharmaceuticals, Inc. announces that RTA 402 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. RTA 402 is currently being studied in a Phase 1/2 trial in patients with pancreatic cancer, and is also in Phase 2 development for chronic kidney disease.

Orchid gets US FDA nod for three Cefuroxime Inj ANDAs (PharmaBiz)
The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals, has received approvals from the US FDA for three of its ANDAs (Abbreviated New Drug Application) for Cefuroxime for Injection, 750 mg & 1.5 g vials (infusion packs), 7.5 g (pharmacy bulk pack) and 1.5 g vial.

FDA Approves Astepro - Nasal Antihistamine In The Treatment Of Rhinitis (Medical News Today)
The U.S. Food and Drug Administration (FDA) has approved Astepro - the new formulation of Astelin. Astepro Nasal Spray is an improvement over the marketed Astelin Nasal Spray and is better tolerated by patients using the new spray. The active substance in these products is azelastine - the leading nasal antihistamine in the treatment of rhinitis in the U.S.
 

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