Alkem Laboratories gets Form 483 from US FDA for St. Louis plant
(adsbygoogle = window.adsbygoogle || []).push({}); Alkem Laboratories said that the US Food and Drug Administration (FDA) has issued Form 483 to the company with two observations. Form 483 More...
Cipla associate Avenue Therapeutics fails to get FDA approval for IV tramadol
Cipla’s step-down associate firm Avenue Therapeutics has failed to get approval from the US Food and Drug Administration (FDA) for IV tramadol as an alternative for reducing the use of conventional opioids in More...
Lupin Limited gets FDA warning letter for Lupin Somerset site
Indian pharma company Lupin Limited said that it has been issued a warning letter from the US Food and Drug Administration (FDA) for its manufacturing facility in Somerset, New Jersey. The warning letter follows More...
Glenmark gets FDA nod for Theophylline Extended-Release Tablets generic
Glenmark Pharmaceuticals has secured final approval from the US Food and Drug Administration (FDA) for Theophylline Extended-Release Tablets, 300 mg, and 450 mg. The Indian pharma company’s Theophylline Extended-Release More...
LUMAKRAS FDA approval : Amgen bags approval in KRAS G12C-mutated NSCLC
LUMAKRAS FDA approval : Amgen has bagged accelerated approval from the US Food and Drug Administration (FDA) for LUMAKRAS (sotorasib) for the treatment of a type of non-small cell lung cancer (NSCLC) in adults. The More...
Zydus Cadila gets FDA approval for Fluphenazine Hydrochloride Tablets
Cadila Healthcare (also known as Zydus Cadila) said that it has secured final approval from the US Food and Drug Administration (FDA) to market Fluphenazine Hydrochloride Tablets 1 mg, 2.5 mg, 5 mg, and 10 mg. The More...
Natco Pharma gets FDA approval for Lenalidomide Capsules
Natco Pharma has secured the final approval from the US Food and Drug Administration (FDA) of its abbreviated new drug application (ANDA) for Lenalidomide Capsules, 5mg, 1 Omg, 15mg, and 25mg, and the tentative More...
Unichem Laboratories gets FDA approval for Amitriptyline HCl Tablets generic
Unichem Laboratories, an Indian specialty pharma company, said that it has secured abbreviated new drug application (ANDA) approval for its Amitriptyline HCl Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 More...
Alembic Pharmaceuticals gets FDA approval for Lurasidone Hydrochloride Tablets
Alembic Pharmaceuticals has secured final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, More...
Transcenta gets US FDA clearance for launching phase 1 trial of TST005
Transcenta has secured clearance of its investigational new drug (IND) application for TST005 from the US Food and Drug Administration (FDA) for launching a phase I clinical trial of the bi-functional anti-PD-L1/TGF-β More...
