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…
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Browsing Tag
US FDA approval
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…
FDA approves Roche’s Vabysmo to treat nAMD and DME
Vabysmo is the only injectable eye medicine approved simultaneously in the US for neovascular Age-related Macular Degeneration…
Glenmark gets nod from US FDA for generic drug
The product is a generic version of Bausch Health US LLC's MetroGel-Vaginal
US FDA approves second indication for Skyrizi to treat adults with active psoriatic arthritis
Skyrizi maintains a dosing regimen for PsA that is consistent with the existing regimen for moderate-to-severe plaque psoriasis…
Zydus receives final approval from US FDA for Vigabatrin tablets
Vigabatrin is used to treat babies, one month to two years old with infantile spasms
Strides Pharma’s Singapore arm gets US FDA nod for generic version of oseltamivir phosphate
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tamiflu for oral suspension, 6…
US FDA approves drugs from AbbVie and Pfizer to treat eczema
AbbVie’s Rinvoq and Pfizer’s Cibinqo have been approved to treat moderate-to-severe eczema, in patients who do not respond to…
Glenmark gets US FDA nod for nasal spray to treat seasonal allergic rhinitis
With this NDA approval, the company looks forward to bringing this new medicine to physicians and their patients for the treatment…