Lupin gets US FDA approval for Droxidopa Capsules
The product will be manufactured at Lupin’s facility in Nagpur, India
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Drug approvals
Zydus Cadila gets final nod from USFDA for Droxidopa Capsules
It is indicated for use in people with conditions of the nervous system that can cause low blood pressure
Unichem Laboratories gets USFDA approval for Apremilast Tablets
Apremilast tablets are indicated for the treatment of plaque psoriasis
Granules India gets US FDA approval for Potassium Chloride ER Capsules
Potassium Chloride is indicated for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis…
Pfizer gets US FDA approval for PANZYGA to treat chronic inflammatory demyelinating polyneuropathy
It is the only FDA-approved intravenous immunoglobulin with two maintenance dosing options for CIDP
Strides gets USFDA approval for Prednisone Tablets
Prednisone is a corticosteroid used as an anti-inflammatory or an immunosuppressant medication to treat different conditions such…
Alembic Pharma subsidiary, Alembic Global Holding SA gets USFDA final nod for Treprostinil injection
Treprostinil injection is indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with…
Biocon Biologics and Viatris get EC Approval for Kixelle, biosimilar insulin Aspart
Kixelle, a fast-acting insulin analog indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1…
Glenmark gets USFDA approval for Clindamycin Phosphate Gel
It is an antibiotic indicated for the treatment of acne
AbCellera gets EUA from US FDA for its antibody Bamlanivimab, along with Etesevimab for COVID-19
Lilly plans to manufacture more than 250,000 doses of the bamlanivimab and etesevimab therapy throughout Q1 2021, and up to a…
Lupin gets US FDA nod for Tavaborole Topical Solution
It is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or…
Rhizen Pharma’s partnered asset Umbralisib gets US FDA accelerated nod for relapsed or…
Umbralisib is a novel, next generation, oral, once daily, inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1…
Granules India gets US FDA nod for Potassium Chloride Oral Solution
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis
SeQuent Scientific gets CEP for its generic API Diclazuril in EU
Diclazuril is an antiprotozoal drug to treat coccidiosis in livestock and equine protozoal myeloencephalitis caused by Sarcocystis…
US FDA grants Orphan Drug Designation to Zydus’ Saroglitazar for primary biliary cholangitis…
This follows the grant of ‘Fast Track Designation’ by the USFDA to Saroglitazar Mg for PBC in December 2020
Glenmark Pharma gets USFDA approval for Amphetamine Sulfate Tablets
The tablets are used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy, a sleeping disorder
Unichem gets USFDA approval for Zonisamide Capsules
They are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy
Strides get USFDA nod for Ursodiol capsules
Ursodiol capsules are indicated for the treatment of patients with Primary Biliary Cirrhosis (PBC)
Lupin gets USFDA approval for Sevelamer Carbonate Tablets
They are indicated for the control of serum phosphorus in adults and children six years of age and older with chronic kidney…
Zydus Cadila gets US FDA nod for Liothyronine Sodium Tablets
It is a man-made form of thyroid hormone which is used to treat an underactive thyroid (hypothyroidism)