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
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Browsing Tag
US FDA approval
Strides receives US FDA approval for Amantadine Hydrochloride Softgel capsules
Capsules to be marketed by Strides Pharma Inc in the US market
Lupin gets FDA approval of sNDA for Solosec
The supplemental adolescent approval enhances Solosec's strong position as the first and only single-dose oral prescription…
US FDA gives clearance to AffaMed’s bispecific biologic to treat retinal vascular diseases
AffaMed will soon initiate a phase-I study in the US to investigate the safety, tolerability, pharmacokinetics and efficacy of…
US FDA grants Orphan Drug Designation to BCMA CAR-T cell therapy co-developed by Innovent Biologics…
ODD will accelerate drug development and registration action in the US
US FDA authorises Eli Lilly’s COVID-19 antibody drug
The FDA authorised bebtelovimab for emergency use in patients with mild-to-moderate COVID-19 who are at high risk of progression…
Zydus gets 180 days’ shared exclusivity for Roflumilast tablets
Zydus’ Roflumilast tablets are indicated as a treatment to reduce the risk of Chronic Obstructive Pulmonary Disease (COPD)…
Lupin receives approval from US FDA for Arformoterol Tartrate inhalation solution
Arformoterol Tartrate inhalation solution 15 mcg (base)/2 ml, unit-dose vials are indicated for the long-term maintenance…
Theseus Pharmaceuticals receives US FDA Orphan Drug Designation for THE-630 to treat Advanced…
For patients living with GIST, progression through standard lines of therapy is often associated with the emergence of resistance…
Alembic Pharma receives US FDA tentative approval for Fesoterodine Fumarate extended-release tablets
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Toviaz extended-release…