Drug Approval | 26 January 2024
Zydus receives USFDA’s final approval for Gabapentin Tablets, 300 mg and 600 mg
Gabapentin is indicated for the management of Postherpetic Neuraligia
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
Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of US $5 million in the US
The company has received five final approvals
Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis
The product is expected to be launched in December 2023
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure
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