Shilpa Medicare's plant in Telangana bags US FDA clearance
The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited (Parent Organization) and its agreed parties
US FDA Approval | 23/09/2022 | By Sudeep Soparkar | 477
Palette Life Sciences bags US FDA approval for Barrigel rectal spacer
The spacer protects prostate cancer patients during radiation therapy
US FDA Approval | 13/06/2022 | By Sudeep Soparkar | 529
US FDA approval for Incyte's Olumiant
Eli Lilly and Company and Incyte announced the US Food and Drug Administration (FDA) has approved Olumiant (baricitinib) for the treatment of Covid-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) with a recommended dose of 4-mg once daily for 14 days.
US FDA Approval | 12/05/2022 | By Sudeep Soparkar | 418
Generic Pradaxa Capsules from Alembic Pharma given tentative approval by the US FDA
Alembic Pharmaceuticals Limited has gotten speculative endorsement from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for dabigatran etexilate cases, 75 mg, 110 mg, and 150 mg.
US FDA Approval | 08/04/2022 | By Sudeep Soparkar | 640
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