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Results For "USP"

444 News Found

Inceptua Early Access and Sentynl Therapeutics launch early access program for Nulibry for pediatric patients
News | October 19, 2022

Inceptua Early Access and Sentynl Therapeutics launch early access program for Nulibry for pediatric patients

MoCD Type A is a rapidly progressive autosomal recessive inborn error of metabolism resulting in toxic sulfite levels causing neurologic sequelae


Zydus receives tentative approval from USFDA for Roflumilast tablets
Drug Approval | October 18, 2022

Zydus receives tentative approval from USFDA for Roflumilast tablets

Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data


Zydus receives tentative approval from USFDA for Valbenazine capsules
Drug Approval | October 18, 2022

Zydus receives tentative approval from USFDA for Valbenazine capsules

Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data


ANDA approval from USFDA for Unichem's Extended Phenytoin Sodium Capsules
Drug Approval | October 15, 2022

ANDA approval from USFDA for Unichem's Extended Phenytoin Sodium Capsules

Extended Phenytoin Sodium Capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures


Presss note on WHO Medical product alert regarding Maiden Pharmaceuticals
News | October 07, 2022

Presss note on WHO Medical product alert regarding Maiden Pharmaceuticals

DSCO has requested WHO to share at the earliest with CDSCO the report on establishment of causal relation to death with the medical products in question etc.


Zydus receives final approval from USFDA and 180 days shared exclusivity for Brivaracetam Tablets
Drug Approval | October 07, 2022

Zydus receives final approval from USFDA and 180 days shared exclusivity for Brivaracetam Tablets

Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.


Zydus receives USFDA tentative approval for Amantadine Extended-Release capsules
Drug Approval | October 05, 2022

Zydus receives USFDA tentative approval for Amantadine Extended-Release capsules

Amantadine Extended-Release capsules had annual sales of US $2.7 million in the United States according to IQVIA data


Zydus receives approval from USFDA for Mirabegron Extended-Release Tablets
Drug Approval | October 04, 2022

Zydus receives approval from USFDA for Mirabegron Extended-Release Tablets

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency


Zydus receives tentative approval from USFDA for Sugammadex Injection
Drug Approval | September 19, 2022

Zydus receives tentative approval from USFDA for Sugammadex Injection

Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery


Zydus receives final approval from USFDA for Lenalidomide Capsules
Drug Approval | September 15, 2022

Zydus receives final approval from USFDA for Lenalidomide Capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India