Lupin gets nod from EC for Orphan Drug NaMuscla

Lupin has received approval from European Commission (EC) for NaMuscla (mexiletine) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. NaMuscla reduces myotonia symptoms in adult patients, resulting in a … Read more

Lupin’s Nagpur facility receives EIR from USFDA

Lupin has received the Establishment Inspection report (EIR) post the completion of a Pre-Approval Inspection (PAI) for its Phenytoin Sodium Extended Release 100 mg capsules, carried out by The United States Food and Drug Administration (USFDA) at its Nagpur facility in Maharashtra. The inspection conducted in September 2018 concluded without any observations. Lupin’s Nagpur facility … Read more

Lupin’s US arm recalls 6,752 bottles of Testosterone Topical solution from US

Lupin’s US subsidiary, Lupin Pharmaceuticals Inc is recalling 6,752 bottles of Testosterone Topical solution in the strength of 30mg/1.5mL from the American market on account of defective container. The product is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. The reason for recall is Defective Container … Read more

Lupin receives USFDA’s approval for generic Triamcinolone Acetonide Ointment

Lupin has received approval for its Triamcinolone Acetonide Ointment USP, 0.1% from the United States Food and Drug Administration (FDA) to market a generic version of Mylan Pharmaceuticals, Inc.’s (Mylan) Triamcinolone Acetonide Ointment, 0.1%. Lupin’s Triamcinolone Acetonide Ointment USP, 0.1% is the generic version of Mylan’s Triamcinolone Acetonide Ointment, 0.1%. It is indicated for the … Read more

Lupin Neurosciences receives positive CHMP opinion for NaMuscla

Lupin Neurosciences, a specialty pharma division of Lupin has announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of NaMusclaim (mexiletine hydrochloride) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. … Read more

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