NEW DRUG APPLICATION

Zydus Cadila gets USFDA nod for antidepressant drug

Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Nortriptyline Hydrochloride ...

Strides Pharma Science arm gets American drug regulator's nod for pain relieving drug

Strides Pharma Global Pte. Limited, Singapore, has received approval for Ibuprofen Oral Suspension USP, 100 mg/5 mL from the United States ...

USFDA rules against Sun Pharma Advanced Research Co's appeal regarding cancer drug application

The Office of New Drugs (OND) of the US Food and Drug Administration (FDA) has denied the company's appeal of the Complete Response Letter ...

Aurobindo Pharma gets USFDA nod for generic Droxidopa capsules

The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Droxidopa capsules in th...

Zydus Cadila gets USFDA nod for low blood pressure drug

Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Droxidopa capsules in the st...

Unichem Laboratories gets USFDA nod for plaque psoriasis treatment drug

Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for photot...

Lupin launches Posaconazole delayed-release tablets

In a regulatory filing, Lupin Ltd announced launch of Posaconazole delayed-release tablets, 100 mg, after its alliance partner AET Pharma U...

Alembic Global Holding SA gets USFDA nod for pulmonary arterial hypertension treatment injection

Drug firm Alembic Pharmaceuticals on Friday said its arm, Alembic Global Holding SA, has received approval from the US health regulator for...

Strides Pharma receives USFDA approval for Prednisone tablets

Strides Pharma Global Pte Limited, Singapore, has received approval for Prednisone tablets USP in the strengths of 10 mg and 20 mg from the...

Glenmark gets USFDA nod for acne treatment drug

Glenmark Pharmaceuticals has received final approval by the United States Food and Drug Administration (USFDA) for Clindamycin Phosphate Ge...

Glenmark Pharma gets USFDA nod for seizure treatment drug

Glenmark Pharmaceuticals Ltd has received final approval from the United States Food and Drug Administration (USFDA) for Topiramate extende...

Granules arm gets American health regulator's nod for Potassium Chloride Oral Solution

In a BSE filing, Granules said the US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed b...

Avenue Therapeutics gets regulatory update for intravenous tramadol, says Cipla

In October this year, Avenue Therapeutics Inc had received a complete response letter (CRL) from the USFDA which stated that the regulator ...

Zydus Cadila files investigational new drug application for COVID-19 treatment

Drug firm Zydus Cadila on Tuesday said it has filed the investigational new drug (IND) application for ZYIL1, positioned for management of ...

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...

Unichem Laboratories gets USFDA nod for drug to treat irregular heartbeat

Drug firm Unichem Laboratories on Wednesday said it has received approval from the US health regulator for its Amiodarone tablets used to t...

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 ...