Lupin, Unichem, Alembic & Zydus okayed to sell generic Cialis in US

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 […]

Lupin, YL Biologics get nod to sell rheumatoid arthritis drug in Japan

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 […]

Lupin, Natco get FDA nod to launch generic version of Gleevec cancer drug

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 […]

Lupin launches exclusive generic version of Ranexa heart drug in US

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 […]

US FDA issues observations on Lupin Pithampur plant

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 gets EU approval for own muscle disorder drug

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 […]

Lupin gets USFDA nod for Sunovion’s bipolar drug Latuda

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 […]

Lupin gets USFDA nod for blood treatment drug

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 […]

Lupin gets USFDA nod for asthma inhaler drug

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 […]

Lupin launches pneumonia drug Atovaquone in the US

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 […]

Lupin to distribute Eli Lilly’s diabetes drug in India

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 […]

Lupin launches Clobetasol Propionate corticosteroid cream in US

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 […]

Lupin’s Goa plant completes successful inspection by UK MHRA

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 […]