Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals
Inspection included drug device combinations covering our recent filing in nasal sprays domain
US revenue increased 43% to $12.9 billion, fueled by a 50% jump in volume, partially offset by a 7% decline in realized prices
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates
The company maintained a competitive ARPOB while steadily improving occupancy, driven by higher patient volumes and efficient capacity utilization
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
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