Lupin receives U.S. FDA approval for generic Ipratropium Bromide nasal spray
Approval allows marketing of generic equivalent of Atrovent Nasal Spray in the U.S.
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Drug approvals
Lupin and Natco secure US FDA approval for generic Bosentan tablets for oral suspension
Natco receives first-to-file exclusivity for Bosentan Tablets for Oral Suspension, 32 mg, in the US market
Lupin receives tentative FDA approval for generic Darunavir combination tablets
It will be manufactured at Lupin’s Nagpur facility in India
USFDA approves novel non-opioid treatment for moderate to severe acute pain
Vertex Pharmaceuticals’ Journavx is the first drug to be approved in this new class of pain management medicines
Novo Nordisk’s Ozempic gains USFDA approves to cut risk of diabetic kidney disease progression
The approval was based on data from a late-stage study, which showed that Ozempic helped cut the risk of death from chronic kidney…
Lupin gains USFDA approval for Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension
The fixed-dose combination is indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and…
USFDA lifts clinical hold on Opella’s planned actual use trial to switch Cialis from prescription to…
Cialis (tadalafil) in the US is currently only available with a prescription. Cialis is a tablet taken to treat erectile…
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…
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