Centre clarifies reasons for delay in approvals for remdesivir
Informs that it is awaiting data on some crucial parameters from companies that have applied for manufacturing and marketing…
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Drug approvals
FDA approves drug to treat infants and children with HIV
The safety and effectiveness of Tivicay and Tivicay PD were supported by a trial that included 75 HIV-1–infected infants, children…
Caplin Steriles gets USFDA approval for Phenylephrine Hydrochloride Injection USP
It is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of…
Dr Reddy’s announces launch of Colchicine Tablets USP in the US
It is available in 0.6 mg tablets in bottle count sizes of 30s and 100s
Zydus Cadila get US FDA approval for Atazanavir capsules
It is used to treat HIV infection, in combination with other antiretrovirals
Strides receives USFDA approval for Triamcinolone Acetonide Ointment
Product approval from flagship facility in Bangalore, to be marketed by Strides Pharma in the US
Aleor Dermaceuticals receives USFDA nod for scalp psoriasis product
Clobetasol Propionate Shampoo, 0.05%, has an estimated market size of $28 million for twelve months ending December 2019 according…
Zydus Cadila receives tentative US FDA approval for Droxidopa Capsules
Droxidopa is used to treat symptoms of low blood pressure when standing, caused by a medical condition called neurogenic…
US FDA approves Retevmo for lung, thyroid cancers with certain genetic mutations
It is the first therapy approved specifically for cancer patients with the RET gene alterations
Aurobindo Pharma receives USFDA approval for Flucytosine Capsules
Flucytosine Capsules are indicated for the treatment of serious infections caused by susceptible strains of Candida and/or…
Zydus gets tentative USFDA approval for empagliflozin and metformin hydrochloride tablets
Zydus gets tentative USFDA approval for empagliflozin and metformin hydrochloride tablets
J B Chemicals gets USFDA approval for Carbamazepine ER Tablets
The product is a generic version of Tegretol XR tablet in the same strength of Novartis Pharma
US FDA approves first therapy for treatment of low-grade Upper Tract Urothelial Cancer
This is the first approval specifically for patients with low-grade UTUC and provides an option for some patients who may…
Lasa Supergenerics gets FDA nod for progesterone API
Progesterone is one of the 26 drugs that had a restriction for exports due to COVID 19 pandemic as a result of India’s import…
Cipla receives final approval for generic version of Proventil HFA Inhalation Aerosol
Cipla’s Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation, is the first AB-rated generic therapeutic equivalent version…
Cipla receives final approval for generic version of AstraZeneca Pharmaceutical’s Nexium…
With this, Cipla has become the first company to file for the 10 mg variant strength of the product
Glenmark receives ANDA tentative approval for Dapagliflozin Tablets, 5 mg and 10 mg
According to IQVIATM sales data for the 12 month period ending January 2020, the Farxiga Tablets, 5 mg and 10 mg market achieved…
Zydus announces world’s first drug for the treatment of Non-Cirrhotic NASH
Saroglitazar, approved by DCGI becomes the first ever drug anywhere in the world for treatment of Non-Cirrhotic Non-Alcoholic…
Strides receives US FDA approval for Tetracycline Hydrochloride Capsules
The product is a generic version of Achromycin V Capsules, 250 mg and 500 mg, of Avet Pharmaceuticals Inc (previously Heritage…
Biohaven drug wins US FDA approval for use in relieving migraine headaches
A single oral dose of the 75 mg tablet can provide fast pain relief, return patients to normal function within an hour, and remain…