Drug Approval | 19 February 2022
Amneal expands injectables portfolio with four new products
Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market
Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market
Tepmetko is the first and only oral MET inhibitor to be approved in the European Economic Area for treating adult patients with advanced NSCLC harboring alterations leading to METex14 skipping, who require systemic therapy following prior treatment
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
With this approval, Brukinsa is now approved in 44 markets as BeiGene continues to advance its global registration, including the EU, US, and Great Britain
The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV
Parkinson's disease treatment is the first and only carbidopa/levodopa (CD/LD) tablet designed to be divided for precise dosing
Bebtelovimab neutralizes Omicron as demonstrated by pseudo virus and authentic virus data
The three prequalified products are manufactured by the originator company, Roche, but the listings should pave the way for more companies coming forward to seek WHO prequalification
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad
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
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