- Organizations: Lupin Limited
Products
FDA initiates nationwide recall of 2.5M prednisolone acetate eye drops
Federal agency warns that Lupin’s generic of the prescription-based Pred Forte may have the presence of a foreign substance in its formulation.
Products
FDA approves Lupin's Lucentis biosimilar injection
Ranluspec (ranibizumab-hkdz) marks the third ranibizumab biosimilar cleared in the U.S. to treat five retinal indications.
Products
Lupin launches Lotemax generic suspension in the US
Loteprednol etabonate ophthalmic suspension, 0.5%, is indicated to treat postoperative inflammation and pain following ocular surgery, among other conditions.
Products
FDA grants tentative approval for Lupin's Lumify generic eye drops
Brimonidine tartrate ophthalmic solution, 0.025% is indicated to treat ocular redness due to minor irritations in the eye.
Pipeline
Lupin reports positive phase 3 program for Lucentis biosimilar
Global clinical data on LUBT010 determined clinical equivalence between the two, supporting an eventual regulatory submission for FDA approval.
Products
FDA approves Lupin's BromSite generic equivalent for postop inflammation and pain
Company is the first-to-file for generic formulation of bromfenac ophthalmic solution, 0.075%.
Products
Lupin launches bromfenac topical generic equivalent for postop inflammation and ocular pain
Company also secures exclusive first-to-file status of bromfenac ophthalmic solution 0.007% for up to 180 days.
Products
FDA approves ANDA for Lupin's allergic conjunctivitis eye drop
Generic equivalent to Bausch + Lomb’s Alrex offers a lower-cost alternative for patients.
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