Pharma major Cipla dismissed concerns about adverse observations by the US Food and Drug Administration on one of its manufacturing plants in Goa. The Goa plant is one of the company’s largest manufacturing locations for exports, and the observations could affect the company’s trade with the US, media reports had said. The company’s stock fell […]
Pharma major Strides Shasun said it has decided to launch the ‘over the counter’ version of ulcer drug Ranitidine in 150 mg dosage in the US markets immediately. Strides Shasun is already a key player in the US Ranitidine market with 32% market share through its prescription version in 150 mg and 300 mg doses. […]
The United States’ Food & Drug Administration has issued a Form 483 after inspecting Biocon’s Malaysia manufacturing plant, indicating that it found discrepancies during the inspection. Issue of Form 483 means that the plant has not been approved for production of medicines in its current shape, and must be modified under a ‘corrective and preventive […]
Pharma major Lupin said it has launched a generic version of Concordia’s ADHD drug Kapway in the US. Kapvay tablets has annual sales of approximately USD 66 million in the US. It was in November last year that Lupin and Ajanta Pharma said they’d both got approval to launch Clonidine Hydrochloride tablets from the US […]
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 […]
Pharma company Lupin said it has launched a generic version of Pfizer Inc.’s antibiotic Vibra-Tab. The drug has annual sales of around $144 million in the US, the Indian company said. The AB-rated generic was approved by the United States Food and Drug Administration (FDA) earlier. Doxycycline Hyclate Tablets 100 mg is indicated for the […]
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 […]
Pharma Major Lupin said it got the approval of the US Food and Drug Administration to launch a generic version of Bayer’s oral contraceptive Safyral. The branded version has annual sales of around $23 mln in the US. Lupin’s product will be called Tydemy. The combination is indicated for use by women to prevent pregnancy […]
Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that its nasal spray Ryaltris met safety and efficacy goals in a Phase 3 clinical study in treating perennial allergic rhinitis. With the positive results, the company said it plans to submit an application to the USFDA for treating seasonal allergic rhinitis in the first quarter of […]
Biocon and its partner Mylan scored a key victory on Friday as the US Food & Drug Administration approved its cancer-treating biosimilar trastuzumab. “Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan’s ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier […]
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 […]
Pharma major Lupin said it a warning letter from the US Food and Drug Administration for its formulations manufacturing facilities in Goa and Indore on Monday. “We are deeply disappointed to hove received this outcome. While there will be no disruption of existing product supplies from either of these locations, there will likely be a […]
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 […]
The U.S. Food and Drug Administration has sought more data before approving a chemotherapy compound submitted by Mylan and jointly developed by Biocon. The agency issued a ‘complete response letter’. Such letters are issued when an FDA review an FDA review finds that an application for a new drug cannot be approved ‘in its present […]
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 […]
