Drug Approval | May 01, 2025
Strides receives USFDA approval for anti-inflammatory Celecoxib Capsules
Celecoxib Capsules approval complements Strides’ existing products to serve a broader patient base
Celecoxib Capsules approval complements Strides’ existing products to serve a broader patient base
Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings
This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Investment demonstrates confidence in America’s commitment to science and innovation
Merck Wilmington Biotech will serve as a launch and commercial production facility and the future U.S. home for KEYTRUDA
Planned acquisition will strengthen the presence of Merck Healthcare in the United States and expand reach of SpringWorks’ therapeutic innovations to more patients with rare tumors worldwide
Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K
According to IQVIATM sales data for the 12-month period ending February 2025, the Adderall Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market3 achieved annual sales of approximately $421.7 million.
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
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