Pharmaceutical manufacturer Zydus Cadila said it received final approval from the US Food and Drug Administration to launch Atenolol and Chlorthalidone tablets to treat hypertension and chest pain. The company did not reveal the market size of the drug. Atenolol, sold under the brand name Tenormin, is a beta blocker medication used to treat high […]
Pharmaceutical manufacturer Laurus labs said it received final approval from the US Food and Drug Administration to launch a generic equivalent of Concordia Pharmaceuticals’ malaria drug Plaquenil. Hydroxychloroquine is also used for treating diseases like rheumatoid arthritis and lupus and is sold under the brand name Axemal in India. The company also received a tentative […]
Glenmark Pharmaceuticals, a pharmaceutical company headquartered in Mumbai, reported progress in a proof-of-concept study of GBR 830, being studied as a treatment for atopic dermatitis, commonly known as eczema. The company said it was able to notice a decline in atopic dermatitis score during the study involving 62 patients, which also showed that the drug […]
Pharmaceuticals manufacturer Lupin said it has launched an exclusive generic version of Gilead Sciences’ heart drug Ranexa in the US. Ranolazine ER, to be sold in 500mg and 1000mg tablets, is indicated for the treatment of chronic angina or chest pain. “Products like Ranolazine bring significant savings to US consumers and are a key part […]
Pharmaceutical company Lupin said that the US food and Drug administration has issued six observations after an inspection at its Pithampur manufacturing unit. The inspection was conducted between 14th and 25th January said the company. All companies are supposed to observe good manufacturing practices issued by the US FDA when producing food and drugs meant […]
Lupin said the European Commission (EC) has approved mexiletine for the symptomatic treatment of nondystrophic myotonic (NDM) disorders in adults. Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. Lupin’s NaMuscla reduces myotonia symptoms in adult patients, resulting in a significant improvement in […]
India-based pharmaceuticals manufacturer Lupin said it received approval from the US FDA to sell a generic equivalent of Latuda tablets for treating bipolar disorder and schizophrenia in adults. Latuda, a product of Sunovion Pharmaceuticals, has sales of over $3.2 billion in the US alone, making it one of the bigger drugs in the market. Permission […]
Pharma manufacturer Lupin said it has received approval from the US Food and Drug Administration to sell a generic equivalent of Lundbeck Pharma’s seizure drug Onfi. Onfi Tablets, in 10 and 20 mg doses, have annual sales of $601.2 million in the US, making it one of the bigger drugs in the market. Clobazam, the generic name of […]
Pharma major Lupin said it got approval from the US Food & Drug administration to sell a generic equivalent to Biogen’s big-selling multiple sclerosis drug Tecfidera. Tecfidera has annual sales of $3.55 billion in the US, making it one of the biggest drugs in the market. The generic form of the drug is called Dimethyl Fumarate Delayed […]
Alembic Pharmaceuticals Ltd today announced that the company has received approval from the US Food & Drug Administration (USFDA) to sell a generic alternative to Novartis Pharmaceuticals’ allergic conjunctivitis treatment Patanol Ophthalmic Solution. This is first ophthalmic dosage form approval for Alembic pharmaceuticals Limited. The drug, olopatadine hydrochloride ophthalmic solution, has an estimated market size […]
Alembic Pharmaceuticals said it has received approval from the US Food & Drug Administration (USFDA) to sell a generic version of ANI Pharmaceuticals’ hypertension drug Atacand Tablets. Atacand had an estimated market size of US$ 22 million for twelve months ending December 2017 in the US for the three dosages for which approval has been received […]
Sun Pharmaceutical Industries said it agreed to acquire Pola Pharma Inc, a Japanese pharmaceutical company engaged in the research and development, manufacture, sale and distribution of branded and generic products in Japan for $1 million. Pola Pharma had annual revenues of approximately US$ 108 million and net loss of US$ 7 million for the 12 […]
Sun Pharma Advanced Research Company Ltd, the research focused unit of Sun Pharma, said a trial of its cancer formulation, Paclitaxel Injection, “met all the endpoints” of a bioequivalence study and the company was looking forward to filing a new drug application. SPARC’s study involved Paclitaxel and Abraxane. If two products are said to be bioequivalent it […]
Indian pharmaceutical manufacturer Lupin said it received regulatory approval to launch a generic version of AstraZeneca’s asthma inhalation medicine. Budesonide Inhalation Suspension is among medium-sized drugs sold in the United States, with annual sales of around $475 million. It is sold by AstraZeneca under the name Pulmicort Respules Inhalation Suspension. The drug is indicated for the […]
Cipla said is US subsidiary has agreed to acquire a US company developing an intravenous formulation of the pain-relief medicine Tramadol for up to $215 million (Rs 1,500 cr). The transaction will be done in two phases, with a $35 million injection into the company, Avenue Therapeutics, in the form of purchase of new shares for […]
Pharma major Lupin said it has launched pneumonia suspension Atovaquone, a generic substitute for Glaxosmithkline’s Mepron oral suspension. The drug, in the dosage of 750 mg per 5 milliliter, had annual sales of approximately USD 119 million in the US. It is indicated for the prevention of Pneumocystis jirovecii pneuomonia (PCP) in adults and adolescents aged […]
Dr. Reddy’s Laboratories, one of the biggest pharmaceutical companies in India, said it has agreed to sell its API manufacturing unit located in Jeedimetla, Hyderabad, to Therapiva Private Ltd, an emerging generics pharmaceutical company. The company did not reveal the financial details of the deal, but said the transaction is designed as a slump sale […]
Aurobindo Pharma said it received approval from the South African authorities to launch a key anti-HIV drug in the country, following the launch of the medicine in Sub-Saharan Africa. Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (DLT) tablets are the first-line, preferred regimen for HIV patients as per latest WHO guidelines, the company said. “Aurobindo is […]
Pharmaceuticals manufacturer Lupin said it has received US authorities’ approval to sell pneumonia medicine Atovaquone suspension. The drug had sales of approximately USD 117.4 million per year in the US. The 750 mg/5 mL oral solution is the generic version of GlaxoSmithKline’s Mepron Oral Suspension. It is indicated for prevention and acute oral treatment of […]
Pharma major Lupin said it has launched corticosteroid cream Clobetasol Propionate in the US. The cream is the generic equivalent of Fougera Pharmaceuticals Inc.’s Temovate. Clobetasol Propionate Cream USP 0.05% had annual sales of approximately USD 108.6 million in the US. It is used for the relief of the inflammatory and pruritic (itchy) manifestations of corticosteroid-responsive […]
