Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 3

Results For "United-States-Food-and-Drug-Administration"

281 News Found

Orchid Pharma's 'Exblifep' receives USFDA approval
Drug Approval | February 24, 2024

Orchid Pharma's 'Exblifep' receives USFDA approval

Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA


Lupin receives approval from USFDA for Minzoya
Drug Approval | February 17, 2024

Lupin receives approval from USFDA for Minzoya

Minzoya Tablets are indicated for use by females of reproductive potential to prevent pregnancy


Zydus receives USFDA approval for Isosorbide Mononitrate Extended-Release, Tablets USP
Drug Approval | February 17, 2024

Zydus receives USFDA approval for Isosorbide Mononitrate Extended-Release, Tablets USP

Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease)


Lupin launches Ganirelix Acetate Injection in US
News | February 16, 2024

Lupin launches Ganirelix Acetate Injection in US

It is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation


Aparna Group forays into pharma business; Receives USFDA clearance for manufacturing unit
News | February 15, 2024

Aparna Group forays into pharma business; Receives USFDA clearance for manufacturing unit

The company is strongly committed to enhancing customer satisfaction and catering to the discerning needs of renowned pharmaceutical companies


Lupin launches Bromfenac Ophthalmic Solution, 0.075% in US
News | February 14, 2024

Lupin launches Bromfenac Ophthalmic Solution, 0.075% in US

Bromfenac Ophthalmic Solution 0.075% (RLD BromSite) had estimated annual sales of USD 15 million in the U.S.


Zydus receives Tentative Approval from the USFDA for Dexamethasone Tablets USP, 1 mg
Drug Approval | February 10, 2024

Zydus receives Tentative Approval from the USFDA for Dexamethasone Tablets USP, 1 mg

Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions


Zydus receives USFDA’s final approval for Gabapentin Tablets, 300 mg and 600 mg
Drug Approval | January 26, 2024

Zydus receives USFDA’s final approval for Gabapentin Tablets, 300 mg and 600 mg

Gabapentin is indicated for the management of Postherpetic Neuraligia


Lupin receives USFDA’s approval for Febuxostat Tablets
Drug Approval | January 19, 2024

Lupin receives USFDA’s approval for Febuxostat Tablets

Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)