Latest news with #Oxcarbazepine
Business Standard
a day ago
- Business
- Business Standard
Lupin gets USFDA nod for Oxcarbazepine ER tablets
Lupin announced that it has received tentative approval from the U.S Food and Drug Administration (US FDA) for its abbreviated new drug application for Oxcarbazepine extended-release (ER) tablets. Oxcarbazepine ER tablets, 150 mg, 300 mg, and 600 mg are bioequivalent to Oxtellar XR ER tablets, 150 mg, 300 mg, and 600 mg, of Supernus Pharmaceuticals, Inc., and are indicated for the treatment of partial-onset seizures in patients 6 years of age and older. This product would be manufactured at Lupins Nagpur facility in India. Oxcarbazepine ER tablets (RLD Oxtellar XR) had estimated annual sales of $206 million in the U.S. (IQVIA MAT April 2025). Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The companys consolidated net profit surged 114.9% to Rs 772.52 crore on 13.6% jump in net sales to Rs 5,562.20 crore in Q4 FY25 over Q4 FY24. The scrip rose 0.20% to end at Rs 1,999.20 on the BSE.
United News of India
2 days ago
- Business
- United News of India
Lupin gets tentative approval from U.S. FDA for Oxcarbazepine ER Tablets
Hyderabad, June 7 (UNI) Global pharma major Lupin Limited (Lupin) announced on Saturday that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Oxcarbazepine Extended-Release (ER) Tablets, 150 mg, 300 mg, and 600 mg. This product would be manufactured at Lupin's Nagpur facility in India, the Pharma company said in a release. Oxcarbazepine ER Tablets, 150 mg, 300 mg, and 600 mg are bioequivalent to Oxtellar XR® ER Tablets, 150 mg, 300 mg, and 600 mg, of Supernus Pharmaceuticals, Inc., and are indicated for the treatment of partial-onset seizures in patients 6 years of age and older. Oxcarbazepine ER Tablets (RLD Oxtellar XR®) had estimated annual sales of USD 206 million in the U.S. (IQVIA MAT April 2025). UNI KNR BM
United News of India
3 days ago
- Business
- United News of India
ADVISORY : Story withdrawn
07 Jun 2025 | 10:49 PM EDS: File nos DC 11 and 12 - Zee5 unveils new brand identity, is being withdrawn, on the request of the company. They will issue a new release later. see more.. Atria Renewabic launches rooftop solar campaign 07 Jun 2025 | 8:25 PM Bengaluru, June 7 (UNI) Atria Renewabic, a frontrunner in India's renewable energy sector, on Saturday launched a unique community-centric rooftop solar campaign aimed at accelerating solar adoption in Bengaluru's residential neighbourhoods. see more.. Lupin gets tentative approval from U S FDA for Oxcarbazepine ER Tablets 07 Jun 2025 | 8:16 PM Hyderabad, June 7 (UNI) Global pharma major Lupin Limited (Lupin) announced on Saturday that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Oxcarbazepine Extended-Release (ER) Tablets, 150 mg, 300 mg, and 600 mg. This product would be manufactured at Lupin's Nagpur facility in India, the Pharma company said in a release. see more.. G Square Group announces mega township project in Coimbatore 07 Jun 2025 | 8:14 PM Hyderabad, June 7 (UNI) G Square Group, a leading South Indian real estate developer, on Saturday announced G Square Seven Hills, an expansive township project in Coimbatore. see more.. 07 Jun 2025 | 7:27 PM Patna, June 07 (UNI) Indriya, the jewellery brand from the Aditya Birla Group, has launched its second outlet in Patna, reflecting the city's growing appreciation for craftsmanship and exquisite design. see more..
