Tag: US Food and Drug Administration
Pfizer gets LITFULO FDA approval for severe alopecia areata
Pfizer has announced that the US Food and Drug Administration (FDA) has granted approval to LITFULO (ritlecitinib) as a once-daily oral treatment for individuals aged ... Read More
Bayer gets Ultravist FDA approval for contrast-enhanced mammography
Bayer has received US Food and Drug Administration (FDA) approval for Ultravist (iopromide) injection, its iodine-based contrast agent, to be used for contrast-enhanced mammography (CEM). ... Read More
Lupin clinches FDA approval for generic Spiriva HandiHaler
Indian pharma titan Lupin has announced receiving approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Tiotropium Bromide ... Read More
Zydus Lifesciences bags FDA final approval for generic of acne medication
Zydus Lifesciences has received the final approval from the US Food and Drug Administration (FDA) for Minocycline Hydrochloride Extended-Release Tablets in 55 mg, 65 mg, ... Read More
FDA approves Cardio Flow Design’s iTFlow for enhanced cardiovascular diagnosis
The US Food and Drug Administration (FDA) has granted approval for iTFlow, a software solution developed by Cardio Flow Design Inc. (Japan), that improves the ... Read More
Zydus Lifesciences gets FDA final approval for Varenicline Tablets
Zydus Lifesciences has been granted final approval from the US Food and Drug Administration (FDA) to manufacture and market Varenicline Tablets, 0.5 mg and 1 ... Read More
Zydus Lifesciences’ Diclofenac Sodium and Misoprostol Tablets gets FDA final approval
Zydus Lifesciences has secured final approval from the US Food and Drug Administration (FDA) to manufacture and market Diclofenac Sodium and Misoprostol Delayed Release Tablets ... Read More
Granules India gets FDA approval for generic epilepsy drug Levetiracetam
Granules India has announced its receipt of approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam ... Read More
Natco Pharma wins FDA approval for generic colorectal cancer drug
Indian pharmaceutical firm Natco Pharma has gained the US Food and Drug Administration (FDA)'s final approval for its abbreviated new drug application (ANDA) for Tipiracil ... Read More
Zydus Lifesciences’ Ahmedabad plant passes FDA inspection with no observations
AHMEDABAD, INDIA - Indian lifesciences company, Zydus Lifesciences, announced on Tuesday that its injectables manufacturing facility at Zydus Biotech Park in Changodar, Ahmedabad has passed ... Read More