Zydus’ Desidustat gets USFDA orphan drug status for sickle cell diseaseZydus Lifesciences announced a significant development today. The US Food and Drugs Administration has granted Orphan Drug Designation to D...
06 Feb, 2026, 01.53 PM IST
Zydus Lifesciences gets USFDA approval for angina, high blood pressure drugZydus Lifesciences has secured USFDA approval to market Diltiazem Hydrochloride tablets, used for treating angina and high blood pressure, ...
11 Aug, 2025, 12.59 PM IST
Zydus Lifesciences gets USFDA nod to market generic antifungal shampooZydus Lifesciences received approval from the USFDA to market Ketoconazole Shampoo, an antifungal medication, in the US. This approval is f...
10 Mar, 2025, 11.58 AM IST
Sun Pharma-Moebius Medical anti-osteoarthritis pain drug gets USFDA fast track statusSun Pharma and Moebius Medical have received fast track designation from the USFDA for their non-opioid therapy MM-II, aimed at treating os...
06 Sep, 2024, 05.16 PM IST
Zydus Lifesciences gets USFDA nod for generic medicationZydus Lifesciences has received approval from the USFDA to market Amantadine extended-release capsules (68.5 mg) and tentative approval for...
28 Aug, 2024, 04.50 PM IST
Alembic Pharma gets final nod from USFDA for generic drug to treat Parkinson's diseaseThe approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Entacapone tablets is for str...
06 Jan, 2022, 03.44 PM IST
Zydus Cadila gets USFDA nod for generic drugsThe company has received final approval from the US Food and Drug Administration (USFDA) for the medication in 300 mg strength, Zydus Cadil...
17 Oct, 2020, 01.41 PM IST
Zydus Cadila gets US health regulator nod for multiple sclerosis treatment drugZydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Dimethyl Fumarate delayed re...
25 Sep, 2020, 11.22 AM IST
Zydus gets final nod from USFDA for anti-bacterial drugZydus Cadila is a global pharmaceutical company that develops, manufactures and markets a broad range of healthcare therapies. The group em...
02 Jun, 2018, 02.04 PM IST
USFDA denies approval for SPARC's anti-glaucoma eyedropSun Pharma Advanced Research Company (SPARC) today said the US health regulator has not approved its new drug application for anti-glaucoma...
01 Aug, 2015, 12.42 PM IST
No USFDA approval for SPARC's anti-Glaucoma eyedropWhile the FDA did not seek any additional information for supporting clinical data, it sought additional information on certain labeling of...
02 Dec, 2014, 04.19 PM IST
USFDA increases inspections of drug facilities in IndiaUSFDA is increasing its inspections of facilities of drug makers in India to ensure compliance of approved manufacturing norms.
24 Sep, 2013, 02.29 PM IST
- USFDA opens offices in New Delhi and Mumbai
The US Food and Drug Administration opened its offices in New Delhi and Mumbai on Thursday in a bid to provide greater protection to consum...
15 Jan, 2009, 09.07 PM IST
- Polymed to buy US medical device firm for $20 mn
Disposable medical device manufacturer Polymed is set to acquire a US-based medical device company for around $18-20 million.
01 Oct, 2007, 01.28 AM IST
- Lupin gets USFDA nod for Trandolapril
Lupin Ltd on Thursday said it has received US Food and Drug Administration (USFDA) approval for multiple strengths of Trandolapril Tablets ...
14 Jun, 2007, 12.50 PM IST
- Aurobindo bags US nod for Citalpram
The Hyderabad-based Aurobindo Pharma Ltd on Tuesday said its product Citalopram, used in the treatment of depressive disorders, has bagged ...
12 Sep, 2006, 11.30 AM IST
- Cipla gets USFDA approval for HIV drug
Pharmaceutical firm Cipla has got tentative approval from the USFDA for its abbreviated new drug application (ANDA) for anti-HIV/AIDS drug ...
26 Jun, 2006, 12.00 PM IST