Strides gains USFDA approval for Acetaminophen and Ibuprofen Tablets, 125 mg /250 mg
The product is bioequivalent to the reference listed drug (RLD), Advil Dual Action with Acetaminophen, 125 mg /250 mg (OTC), of…
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Drug approvals
CDSCO approves AstraZeneca’s anti-complement medicine Eculizumab
Eculizumab is approved in India to manage two rare diseases- Paroxysmal Nocturnal Hemoglobinuria (PNH) and atypical Hemolytic…
Alembic Pharma gets USFDA final approval for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3…
Brexpiprazole is an atypical antipsychotic used as an adjunctive therapy to antidepressants for the treatment of major depressive…
Lupin launches Minzoya (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate…
Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets (RLD Balcoltra) had an estimated annual sale of…
Lupin secures tentative U.S. FDA approval for Ivacaftor Oral Granules
Approval paves way for Lupin’s entry into Cystic Fibrosis treatment market
CDSCO approves Wockhardt’s new generation oral antibiotic Miqnaf (Nafithromycin)
Miqnaf is an ultra-short course, once-a-day, 3-day treatment for community-acquired bacterial pneumonia (CABP) including those…
USFDA approves injectable version of Bristol Myers Squibb’s Opdivo
The approval includes indications for renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell…
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
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