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 […]

Lupin gets USFDA nod for generic version of Valeant’s Xenazine

Pharma major Lupin said it received final approval for to launch a generic version of Valeant Pharmaceuticals’ Xenazine in the US. Tetrabenazine Tablets, 12.5 mg and 25 mg, has annual sales of approximately USD 288.1 million in the US, according to IQVIA. The tablet is indicated for the treatment of chorea, or involuntary movements associated […]

Lupin gets tentative USFDA approval for billion-dollar testosterone drug

India-based pharma major Lupin said the US drugs regulator has granted it a conditional, or tentative, approval to sell a generic version of the popular testosterone gel AndroGel. AndroGel, made by AbbVie Inc, is a big-selling drug with annual sales of well over $1 bln. AbbVie, which has patents valid up to 2020 on the […]

Lupin launches generic version of Bayer’s birth control pill Safyral

Pharma major Lupin said it launched a generic version of Bayer’s birth control drug Safyral tablets in the US. The company had received FDA approval for the launch in December. The tablets has annual sales of approximately USD 22 million in the US. Lupin’s product will be called Tydemy. The combination is indicated for use […]

Lupin launches testosterone solution in the US

Pharma major Lupin said it has launched a testosterone topical solution in the US for males suffering from the deficiency of the hormone. Lupin’s Testosterone Topical Solution is the generic equivalent of Eli Lilly and Company’s Axiron solution, Testosterone Topical Solution, 30 mg per actuation had annual sales of approximately $179 million in the US, […]