Drug Approval | February 03, 2025
Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations
The inspection was carried out from January 28 to February 1, 2025
The inspection was carried out from January 28 to February 1, 2025
Immedica to commence a cash tender offer to acquire all issued and outstanding shares of Marinus for an enterprise value of approximately US$ 151 million
Sevelamer Carbonate Tablets approval consolidates the company's position in the Sevelamer segment
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)
The company will engage with the agency to resolve the import alert at the earliest.
First and only FDA-approved treatment for seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older
Nearly 1 million people are living with multiple sclerosis in the United States. Spasticity is a commonly reported symptom for MS, with an estimated prevalence of spasticity of 67%
As part of Daiichi Sankyo’s 2030 vision, it plans to strengthen its oncology portfolio
The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval
This product will be manufactured at Lupin's Goa facility in India
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