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 […]
Pharmaceutical major Cipla said it has received US FDA approval to sell a generic version of heart drug Toprol by Aralez Pharmaceuticals. Toprol and its equivalents had US sales of approximately $464 million for the 12-month period ending Aug 2018, the company said. That puts it among mid-sized drugs by sales, versus the $100 mln market size […]
Sun Pharmaceutical Industries said it has got US Food and Drug Administration approval for a new eye drug that will be used for lowering intraocular pressure or IOP in patients with open-angle glaucoma or ocular hypertension. The medicine, latanoprost ophthalmic emulsion, was developed by group company Sun Pharma Advanced Research Co (SPARC), and was licensed by Sun Pharma, […]
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 […]
Pharmaceuticals maker Zydus Cadila said it received the final approval from the USFDA to market inflammation solution Diclofenac Sodium in the country. Diclofenac Sodium topical solution, 1.5%, is a non-steroidal anti-inflammatory drug (NSAID) used for symptomatic treatment of osteoarthritis of the knee. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad, the […]
Cipla and Strides Shasun, two Indian pharmaceutical companies, both said they have started shipping generic versions of Gilead Sciences’ HIV drug Viread after patent protection expired last week. Viread is among the bigger pharmaceutical drugs in the US and has sales of around $725 mln (Rs 4,650 cr) in the US every year. The patent […]
Aurobindo Pharma Limited said it received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fondaparinux Sodium injection — a bioequivalent and therapeutic equivalent to Arixtra of Mylan Ireland. The product, used to prevent deep vein thrombosis (DVT), will be launched next month. “The approved product has an estimated market […]
Glenmark Pharmaceuticals said it has registered its Seretide Accuhaler product in the Nordic region of Europe, including Sweden, Denmark, Norway, Finland and Iceland. “The commercialization of the product would depend on national approval as well as substitution and pricing approvals,” the company said. The product was registered under the decentralized process. The decentralized process is […]
The United States Food and Drug Administration has given Zydus Cadila approval to launch a generic version of the billion-dollar erectile dysfunction drug Cialis when patents expire. The patents are expected to expire in September next year. Cialis and Viagra are the most popular erectile dysfuntion drugs in the world. Cialis, created by Eli Lilly, […]
Glenmark Pharmaceuticals said it got the approval of the United States Food & Drug Administration to launch a generic version of birth control pill Loestrin from Allergan Pharmaceuticals International. The drug had annual sales of approximately $116.8 million. The drug Norethindrone Acetate and Ethinyl Estradiol Tablets will be sold in the 1/20 dosage. Glenmark’s current […]
Strides Shasun Limited said it received approval from the United States Food & Drug Administration (USFDA) to launch a generic version of Diamox Tablets. The primary use of the Acetazolamide is to reduce nausea and dizziness associated with altitude sickness, but the drug is also used in treating certain types of eye probems and to […]
A month after Lupin got it, Ajanta Pharma too said it got the approval to launch a generic version of Concordia Pharmaceuticals Inc.’s ADHD drug Kapvay. Lupin had got the nod in October, and said the drug had sales of around $66 mln in the US. Ajantha Pharma also said it has already launched the […]
Two Indian pharmaceutical companies, Cipla and Glenmark, said they received approval from the US Food and Drug Administration for new drugs. While Cipla got the nod for a drug used to treat a type of blood cancer, Glenmark was approved to sell an oral contraceptive. Cipla got approval to sell a generic version of Otsuka […]
Pharma major Zydus Cadila said it received final approval from the USFDA to market an anti-inflammatory injection Ethacrynate Sodium in the US. The drug is used to decrease the Swelling (edema) caused by various disease conditions such as liver disease, kidney disease, congestive heart failure, cancer etc. and will be produced at the group’s formulations […]
Zydus Cadila said Mexico’s drug regulator granted marketing approval to market its diabetes drug Lipaglyn in Mexico. The drug can be used to bring down cholesterol levels in patients even when conventional therapies like statins fail. “This approval of Saroglitazar in Mexico is a major milestone for the company,” said Chairman Pankaj Patel. Lipaglyn was […]
Biocon said its partner Mylan has resubmitted the marketing application for two substances used to treat cancer — trastuzumab and pegfilgrastim — before European authorities after making changes to their production facilities. The drug applications before the European Medicines Agency (EMA) were withdrawn in August after the authorities refused to issue approval without reinspecting the […]
Pharma giant Cipla said it received final approval to market a generic version of Genzyme’s kidney drug Renvela Tablets in the US. Renvela Tablets had US sales of approximately $1.85 billion for the 12-month period ending August 2017, according to IMS Health. The approval is for Sevelamer Carbonate Tablets, 800 mg, which is an AB-rated […]
Pharma Major Lupin said it received final approval from the United States Food and Drug Administration (FDA) to market a generic version of Concordia Pharmaceuticals Inc.’s ADHD drug Kapvay. It had annual sales of approximately USD 66 million in the US. Clonidine Hydrochloride, the AB rated generic equivalent, is used for the treatment of attention […]
Pharma manufacturer Lupin said it received approval to launch the generic version of US World Meds’ Corgard heart drug. Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg Tablets had annual sales of approximately USD 109.8 million in the US, the Indian drugmaker said. Lupin’s Nadolol Tablets are the AB rated generic equivalent of […]
Zydus Cadila said it received the final approval to launch overactive bladder drug Fesoterodine Fumarate in the US. The sales of Fesoterodine Fumarate Extended-Release Tablets are estimated at $195.5 million. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Fesoterodine is used to treat an overactive bladder with Symptoms of urinary […]
