Zydus Cadila gets US FDA approval for Cisatracurium Besylate Injection
It is a nondepolarising skeletal neuromuscular blocker for intravenous administration
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USFDA
Alembic Pharma gets tentative nod from USFDA for Empagliflozin and Linagliptin tablets
Empagliflozin and Linagliptin tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with…
Aleor Dermaceuticals receives USFDA nod for Desonide lotion
It indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
Granules Pharma receives US FDA approval for Ramelteon tablets
They are used for the treatment of insomnia characterised by difficulty with sleep onset
Lupin recalls around 5.61 lakh pouches of Mibelas 24 Fe in the US
The product, manufactured in India and then supplied in the US market by Lupin Pharmaceuticals, is used to prevent pregnancy
Alembic Pharma receives USFDA approval for Vardenafil Hydrochloride tablets
They are indicated for the treatment of erectile dysfunction
US FDA grants Breakthrough Therapy Designation for Takeda’s Pevonedistat
The investigational drug is for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS)
Lupin, Granules India recall around 9.71 lakh bottles of diabetes drug in the US
Various companies across the globe have announced similar recalls for the product after the USFDA pointed out the presence of NDMA…
Unichem, Lupin voluntarily recall hypertension medicines in the US
Unichem is recalling 1,90,992 bottles of Clonodine Hydrochloride tablets while Lupin is recalling 4,224 bottles of Lisinopril…
US FDA declines approval again for Nabriva’s antibiotic for UTI
The company said it plans to request a meeting with the FDA to discuss the next steps