Lupin receives FDA Approval for Generic version of Zyvox Tablets

LupinPharma Major Lupin Limited announced today that its US subsidiary, Gavis Pharmaceuticals has received final approval for its Linezolid Tablets from the United States Food and Drug Administration (FDA).

The drug is a generic equivalent of Pharmacia & Upjohn Company’s Zyvox Tablets, 600 mg.

Zyvox Tablets had US sales of USD 273.6 million the company further added.

Last week Lupin had received approval to launch Acotiamide 100 mg indigestion tablets in India from the Central Drugs Standard Control Organization.



Cipla redraws Iran plans with new agreement, to invest Rs 121 cr Cipla said its wholly owned subsidiary of the Company in Netherlands will set up a 75% joint venture with Ahran Tejarat Company for manufacturing and marketing of pharmaceutical products in Iran.An earlier agreement executed by the Company with the Iranian firm has been terminated.The total investment will be euro 16.875 million, which comes to about...
Bliss GVS Healthcare wins three-year contract worth Rs 760 cr from Kenya Bliss GVS Healthcare Ltd said it won a three year contract worth $111.40 mln (Rs 760 cr) from Aon Kenya Insurance Brokers Ltd for provision of medical health care services in Kenya. Bliss GVS Pharma Ltd is a pharmaceutical company based in Mumbai, India.Bliss GVS primarily develops, manufactures and markets products across various therapeuti...
Alembic Pharmaceuticals receives FDA approval for hypertension tablets Alembic Pharmaceuticals Ltd said it received approval from the United States Food & Drug Administration for its abbreviated new drug application for Telmisartan and Amlodipine tablets for hypertension.The Telmisartan and Amlodipine Tablets are equivalent to the Twynsta tablets of Boehringer Ingelheim Pharmaceuticals, Inc.An Abbreviated New Drug ...
Lupin launches injectable iron formulations in India Pharma major Lupin Limited said it launched Iron Isomaltoside injectable iron formulation under two brand names “Isofer” and “Jilazo” in India.Lupin acquired the exclusive rights to market, distribute and sell the injectable formulation from Denmark based Pharmacosmos A/S.The product is currently marketed in 33 countries, including 21 European Union coun...
Dr Reddy’s Labs launches osteoporosis drug in the US Dr Reddy's Laboratories Ltd said it launched raloxifene hydrochloride tablets --used to treat osteoporosis -- in the US market.Raloxifene hydrochloride tablets are a therapeutic equivalent generic version of Evista (raloxifene hydrochloride) tablets. A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, r...
Sun Pharma to get dengue vaccine technology from ICGEB Pharma major Sun Pharma said it tied up with research organization International Centre for Genetic Engineering and Biotechnology to develop vaccines for dengue.The vaccine is targeted against all the four serotypes of Dengue virus that cause disease in humans and is being developed to commercialize in Indian and international markets.A serotype is a...
Aarti Industries to return Rs 96 cr to shareholders via buyback Speciality Chemicals company Aarti Industries Ltd said it will buy back12 lakh equity shares at Rs 800 each, aggregating to Rs 96 cr.The company´s Board of Directors approved the equity shares -- representing up to 1.44% of the company's base."The public announcement setting out the process, timelines and other requisite detail will be released in du...
Marksans Pharma gets USFDA approval for synthetic Vitamin D tablets Marksans Pharma Ltd said the United States Food & Drug Administration has given its approval for its paricalcitol capsules -- a synthetic equivalent of Vitamin D.Vitamin D is important for the absorption of Calcium from the stomach and for the functioning of Calcium in the body. Paricalcitol Capsules are therapeutically equivalent to the reference l...
India overdependent on China for medicines – study India may have emerged as a key supplier of generic and affordable medicine for the world market, but it has an "overwhelming dependence" on China for the raw material required to produce these drugs, industry association Assocham said.Indian companies depend on China to supply them with the main raw material in drug making -- known as Active Pharmaceuti...
Lupin licenses taste-masking technology from Monosol for paediatric tablets Pharma Major Lupin Ltd. said its US subsidiary, Lupin Pharmaceutical Inc., has agreed to license technology from Monosol Rx to develop multiple paediatric-focused products.Lupin would develop the pediatric products utilizing MonoSol Rx’s proprietary PharmFilm drug delivery technology.MonoSol Rx’s PharmFilm technology is a drug delivery platform tha...
Cadila to launch immunosuppressant drug in India Cadila Healthcare, a Ahmedabad headquartered pharmaceutical company owned by Zydus Group, said it has partnered with Switzerland-based global biopharmaceutical company Neovii to launch an drug to reduce the strength of the body's immune system in India.The drug named Grafalon is extensively used in solid organ transplants and stem cell transplant, said t...
Almebic Pharmaceuticals receives inspection report from USFDA Alembic Pharmaceuticals Ltd., said it received an Establishment Inspection Report from the United States Food and Drug Administration for the inspection carried out at their formulation facility at Panelav, Gujarat.The FDA has the authority to inspect any establishment in which food is manufactured, processed, packed, or held, in search of contamination....
Shilpa Medicare receives USFDA approval for generic bone marrow drug Shilpa Medicare Ltd said it received an approval from the United states Food & Drug Administration for Azacitidine injection.Azacitidine is used to treat myelodysplastic syndrome - a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells.The approval was received under ...
FDA observations ‘primarily procedural’ – USFDA issued four observations about Cipla's manufacturing facilities in Goa after conducting an audit, the company said. Cipla has three facilities in Goa."The observations were primarily procedural in nature and the company has already responded to these observations," said the pharma company. Further details were not given.The company said it will...
Lupin receives FDA approval for generic Namenda XR dementia capsules Pharma Major Lupin Ltd said it received final approval from United States Food and Drug Administration for selling Memantine Hydrochloride extended-release capsules, a generic version of Allergan’s Namenda XR capsules.Namenda XR extended-release capsules are approved by the USFDA for the treatment of moderate to severe dementia of the Alzheimer's disea...