Drug Approval | September 08, 2025
USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
The U.S. FDA issued a Form 483 with five observations
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
Roche also shared the design of its upcoming Phase III TRONTIER 1 and 2 trials investigating trontinemab in people with early symptomatic Alzheimer’s disease
The company received one observation in the Form-483
The company is addressing these observations comprehensively
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery
Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA
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