USFDA approves Prasugrel tablets by Lupin
The product will be manufactured at Lupin’s facility in Goa
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Drug approvals
Alembic Pharma receives USFDA’s final approval for Fesoterodine Fumarate extended-release…
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Toviaz Extended-Release tablets, 4 mg…
USFDA gives final nod to Zydus Lifesciences’ generic version of insomnia drug
The drug, triazolam, is used on a short-term basis to treat insomnia
Japan approves AstraZeneca’s Calquence for adult patients with treatment-naïve CLL
Calquence was previously approved in Japan for the treatment of adults with relapsed or refractory Chronic Lymphocytic Leukaemia…
US FDA approves TG Therapeutics’ multiple sclerosis drug
The approval by the US Food and Drug Administration (USFDA) widens the number of such drugs available for treating the disorder to…
USFDA approves Roche’s lymphoma therapy
The drug, known chemically as mosunetuzumab, can be administered at a hospital’s outpatient centre, unlike some other follicular…
US FDA approves Acer Therapeutics’ genetic disorder drug
The approval letter, issued recently, said the drug, sodium phenylbutyrate, could be used as an adjunctive therapy to the standard…
Alembic Pharma gets USFDA nod for Fulvestrant injection, 250 mg/5 mL per single-dose syringe
Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer
USFDA approves Alembic Pharma’s sANDA Pregabalin capsules
Pregabalin Capsules are indicated for neuropathic pain, postherpetic neuralgia, and other indications
Glenmark launches FDC of Teneligliptin + Pioglitazone + Metformin
The triple FDC will help improve glycemic control among adults with High HbA1c and high insulin resistance, those whose diabetes…
Lupin gets US FDA approval for Brivaracetam Tablets
The product will be manufactured at Lupin’s facility in Nagpur, India
Glenmark gets ANDA approval for Nicardipine Hydrochloride Capsules, 20 mg and 30 mg
Nicardipine tablets are indicated for the treatment of high blood pressure and to control angina (chest pain)
US FDA approves Mirati’s lung cancer drug
Mirati was seeking approval for the drug for treating patients with advanced lung cancer who have stopped responding to other…
US FDA gives final approval to Zydus’s two capsules
While Silodosin capsules are indicated to treat signs and symptoms of an enlarged prostate gland, Pregabalin capsules are…
US FDA gives final approval to Alembic Pharma’s Desonide cream
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Desonide Cream, 0.05%, of Padagis
DCGI gives nod to Serum Institute’s ebola vaccine for export to Uganda
The vaccine has been developed by the Serum Institute of India (SII), in collaboration with the Oxford University, UK. According…
US FDA approves JB Pharma’s generic Venlafaxine extended-release tablets
The product is based on Osmotic Controlled Release Oral Delivery System (OROS) technology, an advanced and precision controlled…
CDSCO approves AstraZeneca’s Dapagliflozin with additional indication for treating CKD and heart…
Dapagliflozin reduces the risk of sustained eGFR, cardiovascular deaths and hospitalisation for heart failure in adults with…
Eugia Pharma receives US FDA nod for Amphotericin B Liposome Injection
Has an estimated market size of around US$ 145 million for the 12 months ending September 2022, according to IQVIA.
SEZABY approved by US FDA for the treatment of neonatal seizures
First and only product approved for treating neonatal seizures