Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals received final approval from the US Food and Drug Administration to sell generic drug Dextroamphetamine Sulfate. Dextroamphetamine is a central nervous system stimulant used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and in the treatment of narcolepsy (a Special type of sleep disorder), Zydus Cadila said. […]
Zydus Cadila said it received the final approval to sell urine leakage drug Oxybutynin Chloride in the US market. The annual US sales of the drug is about $150.9 million, it said. The US FDA approved dosages of 5 mg, 10 mg, and 15mg. The drug is largely available in generic format. The medicine is […]
Zydus Cadila has received the final approval from the the US Food and Drug Administration to market Hepatitis B drug Entecavir. The drug has sales of $166.3 million in the US, and will be sold in 0.5 mg and 1 mg dosage. It will be produced at the group’s formulations manufacturing facility at the Pharma […]
Glenmark Pharmaceuticals said it received final approval from the United States Food & Drug Administration for marketing a generic version of joint-pain drug Indocin of Iroko Pharmaceuticals. The drug has annual sales of approximately $6.3 million. With this, Glenmark’s portfolio has expanded to 118 products authorized for distribution in the U.S. and 67 pending approvals […]
Alembic Pharmaceuticals said it received approval from the US Food & Drug Administration for selling a generic equivalent of AstraZeneca’s heart drug Atacand. Approval was granted for the sale of candesantan cilexetil in the dosage of 32 mg. Candesartan cilexetil is used for treatment of hypertension in adults and children and treatment of heart failure. […]
Zydus Cadila said it received final approval from the US Food and Drug Administration to market migraine drug Eletriptan Hydrobromide in the US. The drug is currently marketed and manufactured by Pfizer Inc and sold in the US and Canada under the brand name Relpax. The two key patents covering the drug are listed as […]
Aurobindo Pharma said it received final approval from the US Food & Drug Administration to manufacture generic version of kidney drug Renvela from Genzyme. Sevelamer Carbonate oral suspension, 0.8 gm and 2.4 gm is being launched immediately, the company said. The drug had a market size of US$140 million (Rs 900 cr) for the twelve […]
Pharma Major Lupin said received final approval for launching a generic version of Mallinckrodt Inc.’s Roxicodone Tablets in the United States. The drug is used for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, the company said. Roxicodone Tablets has US sales of USD 344 […]
Suven Life Sciences Ltd said it got a patent from Australia and another from the US for a new molecule used for treating disorders associated with Neurodegenerative diseases. The ‘new chemical entity’ patent no 2014358652 from Australia is valid through 2032, while that from the US will last till 2034, the company said. The chemical […]
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 […]
Minister of health and family welfare Anupriya Patel said Lopinavir syrup, the life-saving drug given to infants and toddlers with HIV has been restocked by the National Aids Control Organization. “NACO has done an emergency procurement from a registered manufacturer — McNeil and Argus. The drug has already been supplied and is available throughout the […]
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 […]
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 […]
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 […]
Pharma Major Lupin Limited (Lupin) announced that it received tentative approval from the United States Food and Drug Administration (FDA) for selling Silodosin capsules, a generic version of Allergan Sales’ Rapaflo capsules. Silodosin capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia, or the enlargement of tissue due 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 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 […]
