The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
Cyclosporine Ophthalmic Nanoemulsion is a preservative-free Nanoemulsion that has been approved in South Korea, Peru and several countries in the Middle East for treatment of dry eye syndrome
The approved ANDA is therapeutically equivalent to the reference listed drug product
Partners with Yifan Pharmaceutical to launch Synovian injection for osteoarthritis in China
Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
Ulcerative Colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine
Advancing IGC-AD1 Toward Commercialization as a Treatment for Agitation in Alzheimer's
Adds first-in-class investigational asset, NX-13, to AbbVie's pipeline with the potential to offer a novel approach to the treatment of ulcerative colitis (UC) and Crohn's disease (CD)
ALS is a rare, progressive and fatal neurodegenerative disease, with an average life expectancy of 3 to 5 years from the time of symptom onset
NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections
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