USFDA

Alembic Pharma arm gets tentative USFDA nod for drug to treat pulmonary arterial hypertension

Alembic Global Holdings SA has received tentative approval from the US Food and Drug Administration for its abbreviated new drug applicatio...

USFDA 'closes' warning letter for three sites of Dr Reddy's Laboratories

Drug firm Dr Reddy's Laboratories on Friday said the US health regulator Food has "closed" warning letter issued for three of its sites in ...

Glenmark Pharma gets USFDA nod for generic drug

The company's US-based subsidiary has received final approval from the US Food and Drug Administration (USFDA) for the product which is a g...

Zydus Cadila gets USFDA nod for generic drugs

The company has received final approval from the US Food and Drug Administration (USFDA) for the medication in 300 mg strength, Zydus Cadil...

Dr Reddy's launches Wilson's disease and cystinuria treatment capsules in US

According to IQVIA Health data, the Cuprimine brand and generic market had US sales of approximately USD 80 million MAT for the most recent...

Granules India gets USFDA nod for sleep aid drug

The US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) for Naproxen Sodium and Diphenhydramin...

Zydus Cadila gets US health regulator nod for multiple sclerosis treatment drug

Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Dimethyl Fumarate delayed re...

Lupin recalls around 5.61 lakh pouches of birth control pills in the US market

The product is used to prevent pregnancy. It is manufactured in India and then supplied in the US market by Lupin Pharmaceuticals Inc, the ...

Zydus Cadila gets tentative USFDA nod for generic drug

The company has received tentative approval from the US Food and Drug Administration (USFDA) for the product which is the generic version o...

Lupin, Sun Pharma recall Lisinopril and Clonazepam respectively in the US market

The Mumbai-based drug maker Lupin is recalling 11,688 bottles of Lisinopril tablets USP, 10 mg, which is used to treat high blood pressure,...

Over 158 applications for generic products pending with USFDA for approval: Lupin

Sharing information with company's shareholders, Lupin MD Nilesh Gupta and CEO Vinita Gupta said the company's US business stabilised last ...

Lupin recalls 35,928 bottles of generic antibiotic drug 'Cefdinir' in the US market

As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), the Mumbai-based company is recalling Cefdinir for ora...

Dr Reddy's Laboratories gets USFDA nod for Xeglyze lotion, used for lice treatment

Dr Reddy's Laboratories said it is working to commercialise this product through partners. In a regulatory filing, Dr Reddy's Laboratories ...

Glenmark Pharma gets USFDA nod to market drug for relapsing multiple sclerosis

Drug major Glenmark Pharma said it has received final approval from the US health regulator for Dimethyl Fumarate delayed-release capsules,...

Zydus Cadila gets USFDA nod for manufacturing Doxycycline Injection at Vadodara

Drug firm Zydus Cadila on Thursday said it has received approval from the US health regulator for manufacturing Doxycycline Injection at it...

Strides Pharma gets USFDA nod to market generic headache drug

The product, which will be marketed by Singapore-based Strides Pharma Inc in the US market, is a generic version of Teva's Fioricet with Co...

Zydus Cadila gets final approval from USFDA to market generic tension headache tablets

The company has received final approval from the United States Food and Drug Administration (USFDA) to market Butalbital, Acetaminophen and...