News | June 03, 2021
Lupin announces U.S. FDA acceptance for pegfilgrastim biosimilar application
Pegfilgrastim has estimated annual sales of USD 3.66 billion in the U.S. (IQVIA MAT December 2020).
Pegfilgrastim has estimated annual sales of USD 3.66 billion in the U.S. (IQVIA MAT December 2020).
Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals
The FDA also noted that current prescribing information for GLP-1 RAs already includes warnings about the risk of suicidal thoughts
These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis
Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs
The deliveries bring the innovative medicine to communities heavily impacted by HIV just five months after U.S. FDA approval
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
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