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Results For "Food-and-Drug-Administration"

1262 News Found

Lupin receives approval from U.S. FDA for Varenicline Tablets
News | December 07, 2023

Lupin receives approval from U.S. FDA for Varenicline Tablets

Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.


Zydus receives final approval from the USFDA for Ivabradine Tablets
Drug Approval | December 06, 2023

Zydus receives final approval from the USFDA for Ivabradine Tablets

Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States


Lupin launches Turqoz (Norgestrel and Ethinyl Estradiol) Tablets in US
Drug Approval | December 02, 2023

Lupin launches Turqoz (Norgestrel and Ethinyl Estradiol) Tablets in US

Norgestrel and Ethinyl Estradiol Tablets USP (RLD: Lo/Ovral-28) had estimated annual sales of US $33 million in the US


Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial
Clinical Trials | November 29, 2023

Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial

Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease


Lupin receives tentative approval from USFDA for Canagliflozin Tablets
Drug Approval | November 24, 2023

Lupin receives tentative approval from USFDA for Canagliflozin Tablets

Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor


Lupin receives approval from USFDA for Bromfenac Ophthalmic Solution
Drug Approval | November 24, 2023

Lupin receives approval from USFDA for Bromfenac Ophthalmic Solution

Bromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain


Lupin receives tentative approval from USFDA for Dapagliflozin Tablets
Drug Approval | November 22, 2023

Lupin receives tentative approval from USFDA for Dapagliflozin Tablets

Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US


Lupin receives approval from USFDA for Pitavastatin Tablets
Drug Approval | November 22, 2023

Lupin receives approval from USFDA for Pitavastatin Tablets

Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol


Truqap plus Faslodex approved in the US for patients with advanced HR-positive breast cancer
Drug Approval | November 22, 2023

Truqap plus Faslodex approved in the US for patients with advanced HR-positive breast cancer

First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients