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Glenmark gets US FDA approval for generic version of Daiichi Sankyo’s hypertension drug

Glenmark Pharmaceuticals said it got approval from US authorities to launch a generic version of Daiichi Sankyo's hypertension drug Azor in various dosages.The drug had annual sales of approximately $211.6 million as of May.The approval was obtained from United States Food & Drug Administration for Amlodipine and Olmesartan Medoxomil tablets

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Lupin launches eye drug in the US

Pharma company Lupin said it launched Moxifloxacin Hydrochloride eye solution in the US.Lupin's Moxifloxacin Hydrochloride Ophthalmic solution USP, 0.5% (base), is an AT1 rated generic equivalent of Novartis Pharms Corp.'s Vigamox Ophthalmic solution.It is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the organisms.Vigamox

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Zydus Cadilla gets preliminary USFDA nod for diabetes treatment

Zydus Cadila has received the tentative approval from the USFDA to market Sitagliptin and Metformin Hydrochloride Tablets used for controlling blood sugar levels."This is a fixed dose combination of two anti-diabetic drugs indicated for Type II diabetes mellitus and will be produced at the group's formulations manufacturing facility at the

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Glenmark Pharma gets UK OTC approval for anti-malarial medicine

Glenmark Pharmaceuticals said it received approval from UK authorities for to sell its Maloff Protect anti-malarial medication without prescription.It contains atovaquone and proguanil hydrochloride, and has been available only as a prescription medicine in the UK.The Medicines and Healthcare products Regulatory Agency gave approval for 250mg and 100mg film-coated

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Sun Pharma selects Samsung to manufacture psoriasis drug

Sun Pharma said it has inked a long-term agreement with Samsung BioLogics under which the Korean company will manufacture Tildrakizumab, a potential treatment for plaque psoriasis, for the Indian company.Plaque psoriasis is an autoimmune condition which results in patches of thick, red, scaly skin.The approximate value of the contract will

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Strides Shasun gets USFDA nod for nausea drug

Pharmaceutical company Strides Shasun said it received approval from the United States Food & Drug Administration to sell nausea drug Promethazine Hydrochloride in the country.The US market for Promethazine Hydrochloride tablets is approximately USD 17 Million.It will be sold in three doses ranging from 12.5 mg to 50 mg.Promethazine Hydrochloride

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Unichem Labs says USFDA completes inspection of Goa facility

Unichem Laboratories said the US FDA has completed its inspection of the company's formulations manufacturing facility in Goa.The facility has received an Establishment Inspection Report, the company added."This receipt indicates the successful closure of the inspection and the queries raised during the audit (Form 483). The inspection has

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Zydus Cadila gets nod to sell ADHD drug in USA

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

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Glenmark gets USFDA approval for generic joint-pain drug in US

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.

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NIV to help Sun Pharma test Zika, Dengue and Chikungunya drugs

Sun Pharma announced a tie-up with National Institute of Virology (NIV) under the Indian Council of Medical Research for testing various compounds for treating rapidly spreading viral infections -- Zika, Chikungunya and Dengue.The compounds will include those sourced from plants, animals and chemical entities developed by Sun Pharma. NIV

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Alembic Pharma to launch generic version of AstraZeneca heart drug in USA

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

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Zydus Cadila gets USFDA approval for generic version of popular migraine drug

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

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