Alembic gains USFDA final approval for Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and…
The approved ANDA is therapeutically equivalent to the reference listed drug product, Lamictal XR Extended-Release Tablets, 200…
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Drug approvals
Alembic Pharmaceuticals receives U.S. FDA approval for Paliperidone extended-release tablets
Approval covers Paliperidone tablets for the treatment of schizophrenia and schizoaffective disorder
AstraZeneca India receives CDSCO approval for Durvalumab for specified additional indication
Durvalumab in combination with chemotherapy as neoadjuvant treatment, followed by Durvalumab as monotherapy after surgery, is…
AstraZeneca to launch Palivizumab (Synagis) in India
AstraZeneca will launch Palivizumab (Synagis) in October 2024 in India
Lupin gets US FDA nod for Bumetanide Injection, USP
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of $ 20 million in the US (IQVIA MAT July 2024)
Strides Pharma subsidiary receives USFDA approval for 60 mg Fluoxetine tablets
Strides Pharma Global secures approval for Fluoxetine Tablets, completing its portfolio for the US market
US FDA approves Eli Lilly’s drug for eczema
Eli Lilly’s Ebglyss, a new eczema treatment, gains US FDA approval for patients 12 and older, offering a monthly dosing option and…
Strides gains USFDA approval for Theophylline Extended-Release Tablets, 300 mg and 450 mg
Strides is eligible for 180 days of Competitive Generic Therapy (CGT) exclusivity for Theophylline Extended-Release Tablets, 300…
Alembic gains final USFDA approval for Albendazole Tablets USP, 200 mg
Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms…
ENTOD’s PresVu eye drops gain DCGI approval
PresVu aims to reduce dependency on reading glasses for individuals affected by presbyopia
Zydus gains final USFDA approval for Amantadine extended-release capsules 68.5 mg and tentative…
Eligible for 180 days of generic drug exclusivity for Amantadine extended release capsules, 68.5 mg
Zydus Lifesciences receives U.S. FDA approval for Scopolamine Transdermal System
Zydus gains final approval to market Scopolamine Transdermal System, marking its fifth ANDA approval in the transdermal portfolio…
US FDA approves Emergent’s smallpox vaccine for people at high risk of mpox
FDA approves Emergent's ACAM2000 smallpox vaccine for high-risk mpox patients, amid ongoing global health concerns and recent…
Lupin receives U.S. FDA approval for Brimonidine Tartrate Ophthalmic Solution
Lupin to market generic version of AbbVie's Alphagan P for elevated intraocular pressure, manufactured at its Pithampur facility
Sun Pharma introduces STARIZO (Tedizolid Phosphate) in India for ABSSSI
Sun Pharma has obtained rights from MSD to develop, manufacture and commercialise Tedizolid Phosphate in India
Lupin gains Health Canada approval for biosimilar Pegfilgrastim
Pegfilgrastim is a Pegylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue Filgrastim
Gilead’s Livdelzi wins FDA approval, can challenge Ocaliva dominance in primary biliary cholangitis…
The approval could present a major challenge to Ocaliva (obeticholic acid), which was until recently the sole approved drug for…
FDA approves and authorises updated mRNA COVID-19 vaccines
The mRNA COVID-19 vaccines have been updated with a monovalent component that corresponds to the Omicron variant KP.2 strain…
J&J’s EGFR-mutated advanced lung cancer treatment: amivantamab-vmjw plus lazertinib gains FDA…
The chemotherapy-free regimen showed progression-free survival versus osimertinib
Indoco gains final ANDA approval for Lofexidine Tablets 0.18 mg
Indoco has been granted a CGT designation by the USFDA and being the first approved generic, is eligible for 180 days of CGT…