Drug Approval | August 12, 2021
Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%
It’s an AB-rated generic therapeutic version of Durezol
It’s an AB-rated generic therapeutic version of Durezol
A treatment to prevent extreme symptoms and cut hospitalisation
SAB-185 is currently being evaluated in NIH-sponsored Phase 2/3 adaptive trial
The company is eligible for 12 months exclusivity from launch
OptumRx to make Pear’s three commercial Prescription Digital Therapeutics accessible to patients with Optum formulary access.
The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial
If approved it will bring a second source of MMR vaccine to the US market
The company has also applied to DCGI for Emergency Use Authorization (EUA) for ZyCoVD, the world's first Plasmid DNA Vaccine
A total of 526 brands has seen a reduction of up to 90 per cent in MRP
The drug is indicated for mild and transient episodes of heart block
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