Granules Pharmaceuticals clears US FDA audit
The company had undergone the PAI audit by the US Food and Drug Administration (FDA) from 21st June, 2021 to 25th June, 2021
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US FDA
US FDA to review full approval of Pfizer/BioNTech’s COVID-19 vaccine by January
The target action date does not mean the approval will not happen before January, the US Food and Drug Administration's Acting…
Lupin launches Tavaborole Topical Solution in US
It is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or…
US FDA adds new warning on J&J COVID-19 vaccine for Guillain-Barre´ syndrome
It said J&J vaccine recipients should seek medical attention if they have symptoms including weakness or tingling sensations,…
Unichem Labs gets tentative US FDA approval for Sitagliptin Tablets USP
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes…
Lupin gets USFDA approval of sNDA for SOLOSEC (secnidazole) to treat trichomoniasis
SOLOSEC demonstrated a 92.2 per cent clinically and statistically significant cure rate for patients with trichomoniasis based on…
US FDA accepts Amneal’s Biologics License Application for Bevacizumab
Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA
Lupin gets US FDA approval for Sevelamer Hydrochloride Tablets
They are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis
Aleor Dermaceuticals gets USFDA nod for Testosterone Topical Solution
It is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous…
Avenue Therapeutics gets complete response letter from USFDA for IV Tramadol
The CRL stated that the delayed and unpredictable onset of analgesia with IV tramadol does not support its benefit as a…