Lupin receives US FDA approval for Sildenafil for oral suspension
The product will be manufactured at Lupin’s facility in Goa
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Drug approvals
Indoco Remedies gets final nod from US FDA for Lacosamide tablet
The approval granted by the US Food and Drug Administration (FDA) for Lacosamide tablets is for strengths of 50 mg, 100 mg, 150 mg…
Alembic Pharma receives US FDA final approval for Lacosamide tablets
Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older
US FDA approves new Bristol Myers cancer immunotherapy
The company said it expects the treatment to eventually garner annual sales of more than $4 billion
FDA approves first generic of Symbicort to treat asthma and COPD
Agency supports development of complex generic drug-device combination product to improve competition and access to more…
TGA approves single-dose Kozenis for children with P.vivax malaria
The approval includes a novel, 50 mg tablet that can be dispersed in water, which was developed by GSK in partnership with MMV to…
Zydus receives final approval from US FDA for Colestipol Hydrochloride tablets
Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C…
Alembic Pharmaceuticals receives US FDA tentative approval for Macitentan tablets, 10 mg
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Opsumit tablets, 10 mg, of…
US FDA approves AstraZeneca-Merck’s Lynparza to treat early-stage breast cancer
The approval was based on results from a late-stage study in which the drug showed statistically significant and clinically…
Strides Pharma unit gets US FDA approval for generic product
The company's product, which reduces inflammation and other symptoms of gout, is therapeutically equivalent to Takeda…
Aleor Dermaceuticals receives US FDA final approval for Nystatin and Triamcinolone Acetonide…
The approved ANDA is therapeutically equivalent to the Reference Listed Drug product (RLD) Nystatin and Triamcinolone Acetonide…
Zydus receives DCGI approval for Oxemia to treat anaemia in CKD patients
OxemiaTM (Desidustat) is an oral tablet formulation which is the first-in-India alternative to injectable…
US FDA approves expanded use of Bristol Myers cancer drug Opdivo
The approval was based on data from a late-stage study showing the drug along with chemotherapy improved event-free survival and…
Lupin gets US FDA nod to market generic product
The company has received approval from the United States Food and Drug Administration (FDA) to market the generic version of…
WuXi STA passes first EMA drug product pre-approval inspection for Wuxi city site
The PAI focussed on the drug product manufacturing of an innovative drug for one of WuXi STA’s partners
US FDA approves CTI BioPharma’s bone marrow cancer drug
The drug, Vonjo (pacritinib), belongs to a class of anti-inflammatory treatments called JAK inhibitors, and will compete with…
Lupin launches Sevelamer Hydrochloride tablets in US
The product will be manufactured at Lupin’s facility in Nagpur
Unichem Laboratories receives US FDA approval for divalproex sodium
These are the generic equivalent of Depakote ER (Divalproex Sodium) extended-release tablets 250 mg and 500 mg, of AbbVie Inc
FDA approves Eli Lilly drug to cut death and hospitalisation risk in all heart patients
The drug was approved last year for some adults living with heart failure with reduced ejection fraction, which happens when the…
Zydus receives final approval from US FDA for Dapagliflozin tablets
Dapagliflozin is used with a proper diet and an exercise programme to control high blood sugar in people with type-II diabetes