Drug Approval | February 15, 2022
Avion Pharmaceuticals announces USFDA approval of DHIVY
Parkinson's disease treatment is the first and only carbidopa/levodopa (CD/LD) tablet designed to be divided for precise dosing
Parkinson's disease treatment is the first and only carbidopa/levodopa (CD/LD) tablet designed to be divided for precise dosing
Adds five years of market exclusivity on approval
Nearly 1 million people are living with multiple sclerosis in the United States. Spasticity is a commonly reported symptom for MS, with an estimated prevalence of spasticity of 67%
Arformoterol Tartrate had estimated annual sales of US $ 251 million in the U.S. (IQVIA MAT December 2021)
Restasis has been approved for use in the U.S. for nearly 20 years, but until today, there was no approved generic product of this drug
The tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency
Spikevax has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel
Clarithromycin tablets USP, 250 mg and 500 mg have an estimated market size of US $ 11 million for twelve months ending September 2021 according to IQVIA
Vabysmo is the only injectable eye medicine approved simultaneously in the US for wet AMD and DME, with flexible dosing regimens based on patient need
The audit is a PAI for two of its product applications filed from this facility
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