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USFDA issues 12 observations for three Biocon units in Malaysia expresspharma
July 11, 2019
Biotechnology major Biocon has said US health regulator has issued 12 observations after the inspection of three of its units in Malaysia.
Alembic Pharma gets USFDA nod for seizure treatment drug expresspharma
July 05, 2019
Alembic Pharmaceuticals said it has received approval from the US health regulator for Clonazepam orally disintegrating tablets, used for treatment of seizures.
Laurus Labs finishes USFDA inspection of its API facilities in Visakhapatnam expresspharma
June 21, 2019
Laurus Labs announced that it has completed the US Food and Drug Administration (US FDA) inspection of its API facilities in Units 1 & 3 at Parawada, Visakhapatnam, Andhra Pradesh, with two observations which are procedural in nature.
Zydus’ Nesher Pharma gets final USFDA nod for Lovaza capsules biospectrumasia
June 18, 2019
It is used along with diet and exercise to help lower levels of a certain blood fat (triglyceride)
Aurobindo Pharma gets 10 observations from USFDA for its Unit 3 at Hyderabad expressbpd
June 06, 2019
Aurobindo Pharma gets 10 observations from USFDA for its Unit 3 at Hyderabad - BPD
USFDA concludes inspection of Indoco’s Sterile facility (Plant II) expressbpd
June 06, 2019
The US health regulator made four observations on the pharma company’s Goa plant
Alembic Pharma gets USFDA nod for erectile dysfunction drug expressbpd
March 28, 2019
The approval from the USFDA, is for the company’s abbreviated new drug application (ANDA) for Tadalafil tablets USP, in the strengths of 2.5 mg, 5mg, 10mg and 20 mg.
USFDA nod for generic version of Viagra tablet expressbpd
March 26, 2019
The Mumbai-based company has received approval for its product in various strengths
Zydus Cadila gets USFDA nod to market generic antiviral ointment expressbpd
March 21, 2019
Antiviral drug Acyclovir is used to treat the first outbreak of genital herpes infection and to treat non-life threatening herpes infections of the skin and around the mouth in people with a weakened immune system.
USFDA approves new indication for valve repair device by Abbott biospectrumasia
March 18, 2019
The U.S. Food and Drug Administration has approved a new indication for a heart valve repair device that is intended to reduce moderate-to-severe or severe mitral regurgitation, a leakage of blood backward through the mitral valve into the heart’s left at

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