The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil)
The product will be manufactured at Lupin’s facility in Goa, India
The product patent has been already filed under fast track approval
The drug is designed to provide temporary relief from cough caused by throat and bronchial irritation
Sodium Zirconium Cyclosilicate powder for oral suspension 5g (Lokelma) is indicated for the treatment of hyperkalaemia in adult patients
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.
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