Indian pharmaceutical manufacturers Lupin, Unichem Laboratories and Alembic Pharmaceuticals said that they has received approval from the United States Food and Drug Administration to sell generic versions of Eli Lilly’s Cialis erectile dysfunction tablets, while rival Zydus Cadila said it has already begun selling the tablets on day 1. The patent for Cialis, owned by […]
Pharmaceutical major Lupin said that YL Biologics Limited, its newly formed joint venture with Japanese pharma company Yoshindo Inc has received approval from the Pharmaceutical and Medical Devices Agency (PMDA) for sales of a biosimilar version of Amgen Inc’s Etanercept in Japan. Etanercept, sold under the brand name Enbrel or Benepali. is a biopharmaceutical drug […]
Pharmaceutical major Lupin said that it has launched the generic equivalent of AbbVie Inc’s Synthroid tablets. The Levothyroxine Sodium tablets is used to treat thyroid hormone deficiency, including the severe form known as myxedema coma. It is also used to treat and prevent certain types of thyroid tumors. It is taken by mouth or given […]
Pharmaceutical major Lupin and partner Natco Pharma received approval from the US Food and Drug Administration (FDA) to sell a generic equivalent of Novartis Pharmaceuticals’ Gleevec cancer tablets in the US market. Imatinib Mesylate Tablets, in 100 and 200 mg doses, have annual sales of around $655 million in the United States, Lupin said, making […]
Pharmaceuticals manufacturer Lupin said it has launched an exclusive generic version of Gilead Sciences’ heart drug Ranexa in the US. Ranolazine ER, to be sold in 500mg and 1000mg tablets, is indicated for the treatment of chronic angina or chest pain. “Products like Ranolazine bring significant savings to US consumers and are a key part […]
Pharmaceutical company Lupin said that the US food and Drug administration has issued six observations after an inspection at its Pithampur manufacturing unit. The inspection was conducted between 14th and 25th January said the company. All companies are supposed to observe good manufacturing practices issued by the US FDA when producing food and drugs meant […]
Lupin said the European Commission (EC) has approved mexiletine for the symptomatic treatment of nondystrophic myotonic (NDM) disorders in adults. Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. Lupin’s NaMuscla reduces myotonia symptoms in adult patients, resulting in a significant improvement in […]
India-based pharmaceuticals manufacturer Lupin said it received approval from the US FDA to sell a generic equivalent of Latuda tablets for treating bipolar disorder and schizophrenia in adults. Latuda, a product of Sunovion Pharmaceuticals, has sales of over $3.2 billion in the US alone, making it one of the bigger drugs in the market. Permission […]
Pharma manufacturer Lupin said it has received approval from the US Food and Drug Administration to sell a generic equivalent of Lundbeck Pharma’s seizure drug Onfi. Onfi Tablets, in 10 and 20 mg doses, have annual sales of $601.2 million in the US, making it one of the bigger drugs in the market. Clobazam, the generic name of […]
Pharma major Lupin said it got approval from the US Food & Drug administration to sell a generic equivalent to Biogen’s big-selling multiple sclerosis drug Tecfidera. Tecfidera has annual sales of $3.55 billion in the US, making it one of the biggest drugs in the market. The generic form of the drug is called Dimethyl Fumarate Delayed […]
Pharma major Lupin said the US Food & Drug Administration has given it an Establishment Inspection Report for its Tarapur facility. The company had two months ago pointed out that the inspection, carried out in August, had been completed with one observation related to what it called a “procedural deficiency”. The receipt of an EIR is […]
Pharmaceutical manufacturer Lupin said it received approval from the US FDA for launching Decitabine injection for treating conditions caused by defective blood cells, known as myelodysplastic syndromes. Decitabine for Injection, 50 mg/vial, Single-Dose Vial had annual sales of approximately USD 135.9 million in the US. The drug is the generic equivalent of Otsuka Pharmaceutical Co. Ltd.’s […]
Indian pharmaceutical manufacturer Lupin said it received regulatory approval to launch a generic version of AstraZeneca’s asthma inhalation medicine. Budesonide Inhalation Suspension is among medium-sized drugs sold in the United States, with annual sales of around $475 million. It is sold by AstraZeneca under the name Pulmicort Respules Inhalation Suspension. The drug is indicated for the […]
Pharma major Lupin said it has launched pneumonia suspension Atovaquone, a generic substitute for Glaxosmithkline’s Mepron oral suspension. The drug, in the dosage of 750 mg per 5 milliliter, had annual sales of approximately USD 119 million in the US. It is indicated for the prevention of Pneumocystis jirovecii pneuomonia (PCP) in adults and adolescents aged […]
Pharma major Lupin said its Nagpur plant has passed a Pre-Approval Inspection by the US Food and Drug Administration without incident. The inspection, carried out in September, was related to the manufacture of Phenytoin Sodium Extended Release capsules to be sold in the US market. Lupin’s Nagpur facility is the company’s latest site and manufactures Oral Solid Dosage […]
Pharmaceuticals maker Lupin said it will distribute US-based Eli Lilly and Co’s Aplevant (dulaglutide), a once-weekly injection for type 2 diabetes treatment. Lupin said it expects to make Aplevant available in India this month itself. The two companies already have a partnership dating back to 2011. With this, said Lupin, the partnership has been expanded […]
Pharma major Lupin said the inspection of the US Food and Drug Administration at its Nagpur plant has “concluded without any observation.” Conclusion of an inspection without any observations indicates that the facility was found to be up to the standards expected by the FDA. This inspection was a product specific pre-approval inspection, it said. […]
Pharmaceuticals manufacturer Lupin said it has received US authorities’ approval to sell pneumonia medicine Atovaquone suspension. The drug had sales of approximately USD 117.4 million per year in the US. The 750 mg/5 mL oral solution is the generic version of GlaxoSmithKline’s Mepron Oral Suspension. It is indicated for prevention and acute oral treatment of […]
Pharma major Lupin said it has launched corticosteroid cream Clobetasol Propionate in the US. The cream is the generic equivalent of Fougera Pharmaceuticals Inc.’s Temovate. Clobetasol Propionate Cream USP 0.05% had annual sales of approximately USD 108.6 million in the US. It is used for the relief of the inflammatory and pruritic (itchy) manifestations of corticosteroid-responsive […]
Pharma major Lupin said its Goa facility has successfully completed an inspection by the UK Medicines and Healthcare Products Regulatory Authority. “There were no critical or major observations in the inspection,” it said, indicating that products made at the facility can continue to be sold in the UK market. This is not the first such […]
