Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals
The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa
GRIN-NDD is one of the most complex neurodevelopmental disorders with limited treatment options today
Clinical evidence has consistently highlighted lacosamide’s efficacy and safety.
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity
The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 m
This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
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
Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA
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