Drug Approval | March 27, 2024
FDA approves Merck’s WINREVAIR for treatment of pulmonary arterial hypertension
WINREVAIR is a breakthrough biologic for this rare, progressive disease
WINREVAIR is a breakthrough biologic for this rare, progressive disease
Combination shows consistent benefit across prespecified post-progression outcomes
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
Oscotec has successfully completed phase 2 study in patients with chronic ITP last year
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
Pharma Solutions operates 10 research and development and/or production sites globally
The approved product has an estimated market size of US$ 44.5 million for the twelve months ending January 2024
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India
Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders
PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally
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