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

381 News Found

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


Lupin receives tentative approval from USFDA for Dapagliflozin and Saxagliptin tablets
Drug Approval | January 04, 2024

Lupin receives tentative approval from USFDA for Dapagliflozin and Saxagliptin tablets

Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of US $5 million in the US


Akums to empower mothers with Doxylamine + Pyridoxine extended-release tablets for severe morning sickness
News | December 28, 2023

Akums to empower mothers with Doxylamine + Pyridoxine extended-release tablets for severe morning sickness

This combination aims to offer an effective tool to manage symptoms of nausea and vomiting during pregnancy


Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%
Drug Approval | December 27, 2023

Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%

Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis


Eugia's East Windsor facility gets 10 observations from USFDA
Drug Approval | December 25, 2023

Eugia's East Windsor facility gets 10 observations from USFDA

The plant is yet to start commercial operations


Lupin receives tentative USFDA approval for Sitagliptin Tablets
Drug Approval | December 18, 2023

Lupin receives tentative USFDA approval for Sitagliptin Tablets

Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus