Regulatory | 21 August 2026
Zydus gets USFDA approval for Ascorbic Acid Injection
With this, Zydus Lifesciences now has 448 ANDA approvals and has filed 513 ANDAs with the USFDA as of June 30, 2026
With this, Zydus Lifesciences now has 448 ANDA approvals and has filed 513 ANDAs with the USFDA as of June 30, 2026
The company expands its U.S. respiratory portfolio with an FDA-approved generic equivalent to Flonase, targeting a market with annual sales of nearly US$295 million
After five observations from the global drug regulator, Strides subsequently submitted a comprehensive response addressing the observations along with corrective and preventive actions
The newly approved delivery formats are designed to provide patients with an additional treatment option and support more tailored approaches to treatment across different care settings and patient requirements
The filing is backed by results from the Phase 3 VALOR clinical trial
If approved and launched, the Td5cp Adolescent and Adult could therefore address an important gap in booster vaccination for people aged six years and above
The US FDA has approved Lupin’s Pitolisant Tablets as bioequivalent to Wakix, for the indications specified in the approved product labeling
Tapinarof is a topical aryl hydrocarbon receptor agonist and offers a non-steroidal treatment option for patients with the chronic skin condition
The product is indicated for the treatment of hyperkalemia in adults
The latest approval expands the treatment options available to eligible patients with HER2-positive breast cancer in India, covering both earlier and advanced stages of the disease
The FDA based its approval on results from a randomized, observer-blind, active-controlled Phase 3 trial that enrolled 40,805 adults across 11 countries
The FDA action applies to adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and whose tumors carry the KRAS G12C mutation
The approval makes Datroway the only TROP2-directed antibody drug conjugate approved in the EU to demonstrate an overall survival benefit in the first-line treatment of metastatic TNBC
Investigational menin inhibitor receives second orphan status, with Phase 1/2 and registrational Phase 2 studies underway in acute leukemia
The product will be manufactured at company's injectable manufacturing facility in Gujarat, and marketed in United States through Zydus Pharmaceuticals
The approval marks another milestone in the company's expanding global biosimilars portfolio and strengthens its presence in the highly regulated US biologics market
The approved product has been determined to be bioequivalent to the reference listed drug Valium Injection 10 mg/2 mL (5 mg/mL) marketed by Hoffmann-La Roche Inc
Bioequivalent version of Merck's Bridion targets the reversal of neuromuscular blockade in adult and pediatric surgical patients
The approval marks a major shift in the treatment landscape for people living with NSV
An estimated 850 million people worldwide are living with CKD
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