Zydus Lifesciences Limited, a prominent player in the pharmaceutical industry, has recently received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Lacosamide Tablets USP. These tablets, available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg, are primarily indicated for the treatment of partial-onset seizures […]
Granules India has announced its receipt of approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets USP, in 250 mg, 500 mg, 750 mg, and 1,000 mg strengths. The drug, bioequivalent and therapeutically equivalent to UCB, Inc.’s reference listed drug (RLD), Keppra Tablets, is used […]
Lupin announced that its subsidiary Novel Laboratories has received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System. This product is a generic equivalent of Diastat AcuDial Rectal Delivery System, 10 mg and 20 mg, which is […]
Zydus Lifesciences has bagged final approval for seizures drug Vigabatrin for Oral Solution USP, 500 mg from the US Food and Drug Administration (FDA). Vigabatrin for Oral Solution is a generic version of Sabril for Oral Solution. It is approved to treat refractory complex partial seizures as adjunctive therapy in patients aged two years and […]
Sun Pharmaceutical Industries has secured approval for SEZABY (phenobarbital sodium powder for injection) from the US Food and Drug Administration (FDA) for the treatment of neonatal seizures. According to Sun Pharmaceutical, the approval makes SEZABY the first and only product to be indicated specifically in the US for treating neonatal seizures in term and preterm […]
Unichem Laboratories Limited said that the US Food and Drug Administration (FDA) has approved its abbreviated new drug application (ANDA) for its Extended Phenytoin Sodium Capsules USP, 100 mg. The approved product is a generic version of Dilantin (Phenytoin Sodium) Capsules, 100 mg, of Viatris Specialty. According to Unichem Laboratories, Extended Phenytoin Sodium Capsules have […]
Zydus Lifesciences (previously Cadila Healthcare) said that its US subsidiary Zydus Pharmaceuticals (USA) has bagged final approval to market Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg from the US Food and Drug Administration (FDA). The product is a generic of Briviact, which has approval for the treatment of […]
Lupin Limited said that it has been granted tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. Brivaracetam Tablets is a generic equivalent of Briviact Tablets, 10 mg, 25 mg, 50 mg, 75 […]
Cadila Healthcare (also known as Zydus Cadila) said that it has secured tentative approval from the US Food and Drug Administration (FDA) to market Brivaracetam Tablets in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. Brivaracetam is approved for the treatment of partial-onset of seizures (epilepsy). Zydus Cadila will […]
Glenmark Pharmaceuticals said that it has launched Rufinamide Tablets USP, 200 mg and 400 mg in the US, which is a therapeutic equivalent of Banzel Tablets, 200 mg and 400 mg owned by Eisai. Banzel is indicated for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS). The Indian pharma company said that it was […]