Indoco gets USFDA approval for Olanzapine tablets
Olanzapine is indicated for the treatment of schizophrenia and bipolar disorder
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Drug approvals
Alembic Pharma receives USFDA approval for Vardenafil Hydrochloride tablets
They are indicated for the treatment of erectile dysfunction
Zenara Pharma, a Biophore subsidiary, gets DCGI nod for favipiravir tablets
The company informed that these tablets, to be marketed under brand name Favizen, will be manufactured with in-house API
Lupin gets tentative approval from US FDA for empagliflozin tablets
Empagliflozin tablets are used to treat type 2 diabetes mellitus as an adjunct to diet and exercise
US FDA approves SPRAVATO, antidepressant medication from J&J
The drug indicated to treat adults with major depressive disorder and acute suicidal ideation or behaviour reportedly begins…
Rozlytrek from Roche gets EC approval to treat solid tumours and NSCLC
The approval is based on results from the integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I…
Zydus Cadila gets tentative US FDA approval for Carbidopa and Levodopa extended-release capsules
This medication is used to treat the symptoms of Parkinson’s disease or Parkinson-like conditions
Roche gets US FDA approval for Tecentriq combo to treat advanced melanoma
The approval is based on results from the Phase III IMspire150 study, in which the addition of Tecentriq to Cotellic and Zelboraf…
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)
Avra Laboratories gets CDSCO nod for favipiravir API
The company informed that it is now supplying commercial quantities to Cipla for the launch of Ciplenza
FDA approves Tecartus, cell-based gene therapy to treat relapsed or refractory MCL in adults
It also received ‘Orphan Drug’ designation, which provides incentives to assist and encourage the development of drugs for rare…
Zydus Cadila gets US FDA nod to market generic tension headache tablets
The drug will be manufactured at Nesher Pharma's manufacturing facility at St Louis in the US Zydus Cadila has received final…
DCGI approves Itolizumab for restricted emergency use in COVID-19 treatment
The approval was given after its clinical trials on COVID-19 patients in India was found satisfactory by an expert committee,…
Strides receives USFDA approval for headache drug
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules will be marketed by Strides Pharma in the US market
Astrazeneca’s Dapagliflozin gets DCGI nod for treatment of heart failure
Dapagliflozin (Forxiga) is an SGLT-2 inhibitor that can reduce the risk of cardiovascular death and hospitalisation for heart…
Cipla, Hetero get DCGI nod to manufacture remdesivir
With this move, domestic production of remdesivir for “restricted emergency use” can begin
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
Aleor Dermaceuticals gets US FDA nod for Adapalene Gel USP
It is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older
Umifenovir gets DCGI nod for Phase III clinical trial against COVID-19
CSIR-CDRI has developed the process technology for Umifenovir and licensed the process technology for manufacturing and marketing…
Zydus Cadila gets final US FDA approval for Deferasirox Tablets
It is used to treat iron overload caused by blood transfusions in adults and children who are at least two years old