Alembic Pharma gains USFDA final approval for Ivabradine Tablets, 5 mg and 7.5 mg
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Corlanor Tablets, 5 mg and 7.5 mg, of…
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Drug approvals
Lupin receives tentative U.S. FDA approval for Raltegravir tablets
Lupin may secure 180-day exclusivity to market a generic version of Merck’s Isentress HD
Dr Reddy’s launches BixiBat to treat chronic constipation in India
Elobixibat was approved by the CDSCO after submission of the company's successful Phase-3 clinical trial to the Subject Expert…
Pfizer’s ABRYSVO RSV vaccine approved by FDA for broader adult use
The vaccine is now approved for adults aged 18 to 59 at higher risk of RSV-related respiratory illness, expanding its prior…
Alembic secures USFDA approval for Diltiazem Hydrochloride extended-release capsules
Approval covers 120 mg, 180 mg, and 240 mg formulations for the treatment of hypertension and chronic stable angina
Zydus gains final USFDA approval for Fludrocortisone Acetate Tablets USP, 0.1 mg
Fludrocortisone acetate tablets had annual sales of $ 19.9 mn in the United States (IQVIA MAT July 2024)
Accord BioPharma’s Biosimilar IMULDOSA gains USFDA approval for treatment of chronic inflammatory…
Intas Pharmaceuticals acquired exclusive commercialisation rights to DMB-3115 through a license agreement in 2021
Zydus gains final USFDA approval for Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and…
The tablets are indicated for the acute and maintenance treatment of schizophrenia
Indoco Remedies receives U.S. FDA approval for generic Cetirizine tablets
Indoco Remedies secures final approval from the U.S. FDA for its generic version of Zyrtec Allergy Tablets
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…
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