Phase 2 data highlight consistent and sustained reductions in Intraocular Pressure (IOP), statistically significant (p<0.0001) through six months, with clinically meaningful reductions of 24-30%...
Glaukos Receives Permanent J-code for iDose® TR (travoprost intracameral implant)
Glaukos Announces FDA Approval of iDose® TR (travoprost intracameral implant)
Enforcement Report - Week of June 14, 2023
Enforcement Report - Week of April 13, 2022
Alembic Pharmaceuticals Limited (Alembic) today announced that the Company hasnreceived final approval from the US Food & Drug Administration (USFDA) for itsnAbbreviated New Drug Application (ANDA) Travoprost Ophthalmic Solution USP,n0.004%. The approved ANDA is therapeutically equivalent to the reference listed drugnproduct (RLD), Travatan Ophthalmic Solution, 0.004%, of Alcon PharmaceuticalsnLimited (Alcon). Travoprost Ophthalmic Solution USP, 0.004% is indicated for thenreduction of elevated intraocular pressure in patients with open angle glaucoma ornocular hypertension.
Alembic Pharmaceuticals Ltd's Generic Travoprost Receives Approval in US
Apotex`s Generic Travoprost Receives Tentative Approval in US
According to the latest Enforcement Report of the USFDA, Cadila Pharmaceuticals Ltd is recalling 6 kg of Ondansetron HCI API manufactured by the company on account of microbial contamination of non-sterile product. The voluntary ongoing recall is a class II recall, it added.
Ocular Therapeutix has completed its End-of-Phase 2 review with the US Food and Drug Administration (FDA) for its OTX-TP (sustained release travoprost) product candidate for the treatment of glaucoma and ocular hypertension.nnBased on this review, the company intends to initiate the first of two Phase 3 clinical trials during the third quarter of 2016.