US FDA approves Mirabegron extended-release tablets by Zydus
Mirabegron is indicated for the treatment of Over Active Bladder (OAB) with symptoms of urge urinary incontinence, urgency and…
Sign in
Sign in
Recover your password.
A password will be e-mailed to you.
Browsing Category
Drug approvals
Health Canada approves Ryaltris for treatment of Seasonal Allergic Rhinitis
Ryaltris is a fixed-dose combination therapy that provides relief for the symptoms of SAR, both nasal and ocular, in one…
European Commission approves Roche’s Vabysmo to treat vision loss
Vabysmo is the only injectable eye medicine approved in Europe with phase-III studies supporting treatment at intervals of up to…
US FDA approves Bluebird Bio’s gene therapy for rare neurological disorder
The approval was largely expected after the drug received unanimous endorsement from a panel of outside advisers to the FDA in…
US FDA approves Mallinckrodt’s Terlivaz for injection to treat Hepatorenal Syndrome
Terlivaz is the first and only FDA-approved treatment for adults with HRS involving rapid reduction in kidney function
Singapore grants interim approval for Moderna’s bivalent COVID-19 booster vaccine
The vaccine has been authorised for use as a booster shot in individuals aged 18 years and above who have received the primary…
Health Canada approves Lupin’s Rymti
Rymti is available as an injectable easy-to-use pre-filled pen and a pre-filled syringe
Zydus receives final approval and 180 days shared exclusivity from US FDA for Cariprazine capsules
Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed…
Cipla gets US FDA nod for cancer drug
Cipla's Lenalidomide capsules are therapeutic equivalent generic version of Bristol Myers Squibb's Revlimid (Lenalidomide)…
US FDA approves Venlafaxine Extended-Release Tablets and Pregabalin Extended-Release Tablets by…
Both the drugs will be manufactured at the group’s formulation manufacturing facility at Ahmedabad, SEZ
Lupin receives tentative US FDA approval for Dasatinib tablets
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of $1,569 million in the US (IQVIA MAT June 2022)
Alembic Pharma receives final US FDA approval for Chlorthalidone Tablets USP
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Hygroton Tablets, 25 mg and 50 mg, of…
Unichem gets US FDA nod for generic medication
The company has received approval from the US Food and Drug Administration (FDA) to market its product in the strength of 200 mg
US FDA grants EUA for Novavax COVID-19 vaccine, adjuvanted for adolescents aged 12 through 17 years
Novavax vaccine is the first protein-based COVID-19 vaccine authorised in the US
DCGI approves AstraZeneca’s Lynparza for adjuvant treatment of patients with high-risk early breast…
New data from Olympia phase-III trial suggest that Olaparib demonstrated a statistically significant and clinically meaningful…
Strides Pharma gets US FDA nod for naproxen sodium softgel capsules
The approval by the US Food and Drug Administration (FDA) is for naproxen sodium softgel capsules of 220 mg strength (over the…
Lupin receives US FDA approval for Rufinamide tablets
The product will be manufactured at Lupin’s facility in Goa
Lupin receives approval from US FDA for Meclizine Hydrochloride Tablets USP
The product will be manufactured at Lupin’s facility in Goa
Zydus gets USFDA nod for Prochlorperazine Maleate Tablets
Prochlorperazine tablets are used to treat nervous, emotional and mental conditions, and non-psychotic anxiety
Aleor Dermaceuticals receives US FDA final approval for Adapalene and Benzoyl Peroxide Topical Gel,…
The approved ANDA is therapeutically equivalent to the Reference Listed Drug product (RLD) Epiduo Forte Topical Gel, 0.3%/2.5%, of…