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Results For "United-States-Food-and-Drug-Administration"

396 News Found

Lupin launches Bromfenac Ophthalmic Solution, 0.075% in US
News | February 14, 2024

Lupin launches Bromfenac Ophthalmic Solution, 0.075% in US

Bromfenac Ophthalmic Solution 0.075% (RLD BromSite) had estimated annual sales of USD 15 million in the U.S.


Zydus receives Tentative Approval from the USFDA for Dexamethasone Tablets USP, 1 mg
Drug Approval | February 10, 2024

Zydus receives Tentative Approval from the USFDA for Dexamethasone Tablets USP, 1 mg

Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions


Zydus receives USFDA’s final approval for Gabapentin Tablets, 300 mg and 600 mg
Drug Approval | January 26, 2024

Zydus receives USFDA’s final approval for Gabapentin Tablets, 300 mg and 600 mg

Gabapentin is indicated for the management of Postherpetic Neuraligia


Lupin receives USFDA’s approval for Febuxostat Tablets
Drug Approval | January 19, 2024

Lupin receives USFDA’s approval for Febuxostat Tablets

Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)


Zydus receives USFDA’s approvals for Pimavanserin Capsules, 34 mg and Pimavanserin Tablets,10 mg
Drug Approval | January 18, 2024

Zydus receives USFDA’s approvals for Pimavanserin Capsules, 34 mg and Pimavanserin Tablets,10 mg

Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis


Lupin launches Varenicline Tablets in US
News | January 11, 2024

Lupin launches Varenicline Tablets in US

Varenicline Tablets (RLD Chantix) had estimated annual sales of US $412 million in the US


Unichem receives ANDA approval for Doxazosin Tablets
Drug Approval | January 11, 2024

Unichem receives ANDA approval for Doxazosin Tablets

Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure


Lupin Launches Bromfenac Ophthalmic Solution, 0.07% in US
News | January 10, 2024

Lupin Launches Bromfenac Ophthalmic Solution, 0.07% in US

Bromfenac Ophthalmic Solution, 0.07% is the generic equivalent of Prolensa Ophthalmic Solution, 0.07%, of Bausch & Lomb