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, […]
Pharmaceutical company Biocon has launched KRABEVA, a biosimilar Bevacizumab for the treatment of patients a variety of cancers in India. The biosimilar — or a drug that mimics a natural protein — is useful in treating metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers. It will be priced at […]
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 […]
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 Strides Shasun said it agreed to sell its India branded generics business to Eris LifeSciences Limited for Rs 500 cr in cash. “This transaction is the outcome of the company’s portfolio reprioritization, to focus more sharply on larger regulated markets,” it said. The India branded generics business being divested by Strides had sales […]
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 giant Cipla Ltd said it received final approval for launching a generic version of Astrazeneca’s Pulmicort inhalation suspension for pediatric asthma in the US. The product is available for shipping immediately, Cipla said. Pulmicort Respules and generic equivalents had U.S. sales of approximately $825M for the 12- month period ending September 2017, making them […]
Pharma company Suven Life Sciences Ltd said it received new patents in India, USA and Hong Kong for neurological drugs. The patents — one each in Hong Kong and the US and a couple in India — are valid through 2032, 2030 and 2034. “The granted claims of the patents include the class of selective […]
Pharma giant Zydus Cadila reported excellent numbers for the September quarter, led by rising US revenue that lifted its margins and profits. For the second quarter ended September 30, 2017, Zydus Cadila reported Earnings before Interest, Depreciation and Tax (EBIDTA) of Rs. 857 crores, up by 68% y-o-y. Net profit was up 33% to Rs. […]
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 […]
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 […]
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 […]
Alembic Pharmaceuticals said it bought New Jersey-based generic drug developer Orit Laboratories LLC, which will bring seven approved generics and four applications with it. Orbit has “a team of eight highly experienced scientists,” Alembic said, adding that the firm focuses on developing and filing oral solid and liquid products. “We Welcome Dr. Satish Patel, Founder […]
Pharma major Lupin reported an 8% fall in Q2 revenue to Rs. 3,952 cr. Earnings before Interest, Tax, Depreciation and Amortization (EBITDA) for the quarter fell by 13% to 927 cr. Net profit was also down by 31.3% at Rs 455 cr in in the September quarter. The profit was higher than the mean analyst […]
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 major Lupin said that its US subsidiary, Lupin, Inc has acquired Symbiomix Therapeutics, LLC for a cash consideration of USD 150 million including a USD 50 million upfront and other time‐based payments. In addition, there are sales based contingent payments. Lupin had entered into an option to acquire the company earlier this year. Symbiomix […]
Suven Life Sciences Ltd said it was granted a patent by New Zealand authorities for “a class of selective 5-HT4 compounds” that are being developed to treat neurodegenerative diseases. The compounds are being explored for use in cases of Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia, it said. The new […]
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 […]
