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Results For "USFDA"

1133 News Found

Eugia Pharma receives USFDA approval for Budesonide Inhalation Suspension
Drug Approval | December 01, 2023

Eugia Pharma receives USFDA approval for Budesonide Inhalation Suspension

The product is expected to be launched in FY25


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


Strides receives USFDA approval for generic Suprep bowel prep kit
Drug Approval | November 23, 2023

Strides receives USFDA approval for generic Suprep bowel prep kit

The Product will be manufactured at the company's facility in Bengaluru


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


Strides receives USFDA approval for Levetiracetam Oral Solution
Drug Approval | November 21, 2023

Strides receives USFDA approval for Levetiracetam Oral Solution

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.


Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting
Drug Approval | November 17, 2023

Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting

XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer


Lupin receives USFDA tentative approval for Canagliflozin and Metformin Hydrochloride ER Tablets
Drug Approval | November 08, 2023

Lupin receives USFDA tentative approval for Canagliflozin and Metformin Hydrochloride ER Tablets

This product will be manufactured at Lupin’s Pithampur facility in India