Pharmaceuticals manufacturer Strides Shasun said it received approval from the United States Food & Drug Administration (USFDA) for ibuprofen Tablets 200 mg for over the counter sales. According to Ri data, the US market for ibuprofen Tablets USP 200 mg (OTC) is approximately USD 520 Million. “The approval further strengthens company’s fast growing global OTC […]
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 Application (ANDA) is an application for a […]
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, route of administration, quality, performance, and […]
Mylan N.V. and Biocon Ltd. said they submitted Mylan’s biologics license application for a proposed biosimilar Trastuzumab, to the U.S. Food and Drug Administration. Biosimilar trastuzumab is a proposed biosimilar to branded Trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. HER2-positive breast cancer is a breast cancer that tests positive for […]
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 […]
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. Upon completion of […]
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 […]
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 disease. It does not cure […]
Aurobindo Pharma Limited, a pharmaceutical manufacturing company based in Hyderabad, said it received a tentative approval for HIV drug Dolutegravir from US Food & Drug Administration. It is the first FDA approval of a generic version of Dolutegravir. Through a tie up with ViiV and the Clinton Health Access Initiative, Inc., the product is expected […]
Indian Pharmaceutical company Sharon bio medicine Ltd said it received the Establishment Inspection Report (EIR) from United States Food and Drug Amnistration for its manufacturing plant located at Tajola in Raigad Dist., Maharashtra. The plant, which will make Active Pharmaceutical Ingredients is now approved by the USFDA and the generic drug user fee is pending. […]
Dr. Reddy’s Laboratories Ltd said it launched Paricalcitol Injection, a therapeutic equivalent generic version of Zemplar injection in the United States market approved by the US Food & Drug Administration (USFDA). The Zemplar brand and generic had US sales of approximately $22.5 million for the most recent twelve months ending in July 2016 according to […]
Pharma Major Lupin Limited announced that its US subsidiary, Gavis Pharmaceuticals received a tentative approval from the US FDA for selling Moxifloxacin hydrochloride tablets, a generic version of Bayer Healthcare Pharmaceuticals’ Avelox tablets. Lupin’s Moxifloxacin hydrochloride tablets are the AB rated generic equivalent of Bayer Healthcare Pharmaceuticals Inc.’s Avelox Tablets and can be substituted by […]
Pharma company Dr. Reddy’s Laboratories Ltd said it launched Nitroglycerin sublingual tablets — a therapeutic equivalent generic version of Nitrostat sublingual tablets — in the US market. The medication is used before physical activities (such as exercise, sexual activity) to prevent chest pain (angina) in people with a certain heart condition (coronary artery disease). It may […]
The US Food & Drug Administration issued a warning against casual usage of fluoroquinolone antibiotics, arguably the most widely used broad-spectrum antibiotic in India. USFDA advised that the side effects caused by the use of fluoroquinolone antibacterial drugs would outweigh the benefits for patients who have alternative treatment options. Patients with acute sinusitis, acute bronchitis and uncomplicated urinary […]
Indian pharma major Lupin Ltd announced today that it received tentative approval from the United States Food & Drug Administration to market a generic version of Apotex Technology’s ‘Paxil’ Paroxetine tablets. The medicine is indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder. Tentative FDA approvals do not […]
Pharma company Strides Shasun announced that it received the United States Food & Drug Administration (USFDA) approval for Polyethylene Glycol powder to treat occasional constipation. The powder when consumed as a solution works by softening the stool and increasing the frequency of bowel movement by retaining water in the stool, added the company. Yeterday the […]
NATCO pharma, a Hyderabad based pharmaceutical company, said it received establishment inspection report (EIR) from the U.S. Food and Drug Administration (FDA) for the inspection conducted during the period February 8 – February 12 at its Chemical Division in Chennai. Earlier in mid-August, US FDA had issued an establishment inspection report to Natco Pharma’s for […]
Pharma company Strides Shasun announced that it received the United States Food & Drug Administration (USFDA) approval for generic Ranitidine Tablets, used to treat and prevent ulcers in the stomach and intestines. Ranitidine tablet is the first integrated product approval post merger of Strides and Shasun in 2015. The active ingredient and formulations will be […]
Lupin Ltd announced today that its US subsidiary, Gavis Pharmaceuticals LLC, has received final approval for its Potassium Chloride Extended-Release Capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg) from the United States Food and Drug Administration (FDA). The capsule is for the treatment of patients with hypokalemia, or the deficiency of potassium […]
