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Results For "FDA"

1782 News Found

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


European Commission approves Pfizer’s Talzenna in combination with Xtandi for treatment of metastatic castration-resistant prostate cancer
Drug Approval | January 09, 2024

European Commission approves Pfizer’s Talzenna in combination with Xtandi for treatment of metastatic castration-resistant prostate cancer

TALZENNA is the first and only PARP inhibitor approved in combination with standard of care XTANDI for mCRPC patients in the European Union


Palatin completes sale of Vyleesi to Cosette Pharmaceuticals for up to $171 mn
News | January 02, 2024

Palatin completes sale of Vyleesi to Cosette Pharmaceuticals for up to $171 mn

Vyleesi is the first and only as-needed treatment approved by the Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD)


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


Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment
Drug Approval | December 26, 2023

Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment

US FDA approval based on NEURO-TTRansform Phase III results


Bristol Myers Squibb to buy Karuna Therapeutics for US$ 14 billion
News | December 24, 2023

Bristol Myers Squibb to buy Karuna Therapeutics for US$ 14 billion

Transaction delivers KarXT, a first-in-class M1/ M4 muscarinic receptor agonist with differentiated efficacy and safety


Briefs: Aurobindo Pharma and Granules Pharmaceuticals
Drug Approval | December 20, 2023

Briefs: Aurobindo Pharma and Granules Pharmaceuticals

Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection


Briefs: Torrent Pharmaceuticals and Laurus Synthesis
News | December 17, 2023

Briefs: Torrent Pharmaceuticals and Laurus Synthesis

Laurus Synthesis receives Form 483 with 5 observations from USFDA