News about "US FDA "

Glenmark Introduces Lacosamide Oral Solution

Glenmark’s Lacosamide Oral Solution, 10 mg/mL is bioequivalent and therapeutically equivalent to the reference listed drug, Vimpat Oral Solution, 10 mg/mL of UCB, Inc.

US FDA | 16/12/2024 | By Aishwarya

Sun Pharma Gets US FDA Approval for LEQSELVI for Treatment of Severe Alopecia Areata

Sun Pharmaceutical Industries Ltd. has announced that the US Food and Drug Administration (FDA) has approved LEQSELVI (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata.

US FDA | 26/07/2024 | By Aishwarya |  507

Glenmark Gets ANDA Approval for Topiramate Capsules

Glenmark Pharmaceuticals Ltd. has been granted final approval by the United States Food and Drug Administration (US FDA) for Topiramate Capsules USP, 15 mg and 25 mg.

US FDA | 22/07/2024 | By Aishwarya |  179

Glenmark Gets ANDA Approval for Esomeprazole Magnesium Delayed-Release Capsules

Glenmark has secured final approval by the United States Food & Drug Administration (US FDA) for Esomeprazole Magnesium Delayed-Release Capsules.

US FDA | 15/06/2024 | By Aishwarya

Lupin Gets Tentative Approval from US FDA for Letermovir Tablets

Lupin has secured a tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Letermovir Tablets, 240 mg and 480 mg, to market a generic equivalent of Prevymis Tablets, 240 mg and 480 mg, of Merck Sharp & Dohme LLC.

US FDA | 05/06/2024 | By Aishwarya |  332

Lupin Gets Approval from US FDA for Midostaurin Capsules

Lupin has secured approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Midostaurin Capsules.

US FDA | 18/05/2024 | By Aishwarya |  200

Gland Pharma Receives Nod from US FDA for Rare Muscle Disorder

Gland Pharma Ltd. has received approval from the US health regulator for its generic Edaravone injection to treat amyotrophic lateral sclerosis.

US FDA | 08/05/2024 | By Aishwarya |  150

Lupin Announces Resolution of US FDA Warning Letter for its Goa and Pithampur Facilities

This is after the satisfactory evaluation of the corrective actions taken by the company in response to the Warning Letter that was issued on November 6, 2017.

US FDA | 28/07/2023 | By Manvi |  274

Zydus receives final approval from US FDA for Estradiol Transdermal System

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (US FDA) to manufacture and market Estradiol Transdermal System USP, 0.014 mg/day (weekly) (USRLD: Menostar® Transdermal System).

US FDA | 19/04/2023 | By Sudeep Soparkar |  401

Piramal Pharma gets EIR from US FDA for Sellersville, USA facility

The inspection has now been successfully closed by the US FDA

US FDA | 19/04/2023 | By Sudeep Soparkar |  526