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Glenmark Pharma gets US FDA approval for skin cream generic expresspharma
March 25, 2020
According to IMS Health sales data for the 12 months to May 2017, Desonide Cream, 0.05 per cent, achieved annual sales of approximately USD 44.6 million, Glenmark said.
Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers prnewswire
March 25, 2020
The U.S. Food and Drug Administration took action to increase U.S. supplies to support the U.S. response to COVID-19 ...
FDA OKs Gilead’s paediatric hep C drug pharmatimes
March 24, 2020
Gilead has announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Epclusa (sofosbuvir 400mg/velpatasvir 100mg.
FDA dismisses Jardiance for type I diabetes pharmatimes
March 24, 2020
Eli Lilly and Boehringer Ingelheim have received a complete response letter from the US Food and Drug Administration (FDA) regarding the filing of Jardiance (empagliflozin) ...
FDA Provides Update on Patient Access to Certain REMS Drugs during COVID-19 Public Health Emergency americanpharmaceuticalreview
March 24, 2020
As part of the U.S. Food and Drug Administration’s (FDA) ongoing efforts to address the coronavirus pandemic (COVID-19).
COVID-19 Update: FDA Issues EUA for Point of Care Diagnostic contractpharma
March 24, 2020
First emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.
FDA Provides Access to Certain REMS Drugs contractpharma
March 24, 2020
New guidance allows sponsors and healthcare providers discretion regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing.
Boehringer, Lilly Get Complete Response Letter for Empagliflozin contractpharma
March 24, 2020
FDA is unable to approve sNDA for Empagliflozin in type 1 diabetes.
Glenmark receives ANDA tentative approval for Dapagliflozin Tablets, 5 mg and 10 mg expresspharma
March 24, 2020
According to IQVIATM sales data for the 12 month period ending January 2020, the Farxiga Tablets, 5 mg and 10 mg market achieved annual sales of approximately $1.8 billion.
FDA continues to facilitate development of COVID-19 treatments worldpharmanews
March 23, 2020
The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic.

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