Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions
Developed by Pfizer, Abrocitinib has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) in India
Exblifeb demonstrates remarkable efficacy in treating complicated Urinary Tract Infections (cUTI), pneumonia
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival
The company intends to respond to the two minor observations within the stipulated time
Gabapentin is indicated for the management of Postherpetic Neuraligia
The Pregabalin capsules has a market size of ~US$248 mn per IQVIA
GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023
This product has sales of about US$ 20 million in Europe
Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets
Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)
Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis
The PAI was conducted for two drug product applications (ANDAs) filed from this facility
Keytruda is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients
Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
TALZENNA is the first and only PARP inhibitor approved in combination with standard of care XTANDI for mCRPC patients in the European Union
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