Regulatory | 10 February 2022
USFDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences
Adds five years of market exclusivity on approval
Adds five years of market exclusivity on approval
The vagus nerve is the longest nerve in the body that travels down from the brain to innervate and control breathing, stress levels and inflammation
The Vasostrict brand market had U.S. sales of approximately US $ 878.5 million MAT for the most recent twelve months ending in December 2021 according to IQVIA Health
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%
Singapore Health Sciences Authority (HSA) approval marks the first in a series of expected approvals of trodelvy in Asia
Arformoterol Tartrate had estimated annual sales of US $ 251 million in the U.S. (IQVIA MAT December 2021)
It has a total of 50 ANDA approvals from USFDA
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
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
KEYTRUDA is now approved as monotherapy for adults with Renal Cell Carcinoma (RCC)
Potassium chloride is used to prevent or to treat low blood levels of potassium
Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA
CEQUA’s nanomicellar (NCELL) technology improves the bioavailability and physicochemical stability of cyclosporine to increase ocular tissue penetration
According to IQVIA sales data for the 12-month period ending November 2021, the Ziac tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg market achieved annual sales of approximately US $ 30.3 million
Evrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to date
The drug is to be supplied in 105 low and middle-income countries and 10 Indian firms are on the list
It is the first CAR T Therapy approved for the treatment of multiple myeloma in Japan
Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain
Subscribe To Our Newsletter & Stay Updated
