USFDA restricts imports of 11 Viatris drugs made in Indore facility
It makes exceptions, subject to certain conditions, for four products based on shortage concerns
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Drug approvals
Alembic Pharmaceuticals receive USFDA approval for Divalproex Sodium capsules
Approval marks Alembic’s 193rd final ANDA approval in the United States market
Granules Pharmaceuticals gains U.S. FDA approval for Lisdexamfetamine Dimesylate chewable tablets
New approval supports treatment for ADHD and binge eating disorder while addressing critical drug shortages
Supriya Lifescience gains ANVISA nod for Esketamine Hydrochloride & files patent for…
Supriya Lifescience has developed a technique for low-cost manufacturing of Atorvastatin
Cobenfy could break dopamine dominance in schizophrenia treatment: GlobalData
Cobenfy is a twice-daily oral medication that combines xanomeline, a muscarinic receptor agonist, and trospium chloride, a…
Lupin receives U.S. FDA tentative approval for HIV treatment generic
Lupin to manufacture generic Abacavir, Dolutegravir, and Lamivudine Tablets for Oral Suspension at its Nagpur facility
Gland Pharma secures US FDA approval for Latanoprost Ophthalmic Solution
Product targets treatment of high intraocular pressure in glaucoma and ocular hypertension patients
Biocon Biologics receives FDA approval for biosimilar YESINTEK
The biosimilar Ustekinumab-kfce is set for commercialisation in the US by February 2025 under a licensing agreement with Janssen
Lupin gains tentative USFDA nod for Sitagliptin and Metformin Hydrochloride Tablets
Sitagliptin and Metformin Hydrochloride tablets to market a generic equivalent of Janumet tablets of Merck Sharp & Dohme
Dr. Reddy’s launches Toripalimab under the brand name Zytorvi in India
Toripalimab is an immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma
BridgeBio’s drug for ATTR-CM gains US FDA approval
BridgeBio plans to price the therapy at $18,759.12 for a 28-day supply
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…
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