Pharma company Strides Shasun said it had received approval allergy drug Cetirizine Hydrochloride in the US. “The US market for Cetirizine Hydrochloride Capsules (Softgel) is approximately USD 60 mln, with only one other generic player,” the company said. “The product is ready for launch immediately and as in the case of OTC products, the market […]
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 in dosages ranging […]
Jubilant Life Sciences said it received final approval from US authorities to launch a generic version of Valeant’s anti-depressant Wellbutrin. The approval from FDA is for introducing Bupropion Hydrochloride tablets in 150 mg and 300 mg doses. The drug is used for the treatment of major depressive disorder and prevention of seasonal affective disorder. “This […]
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 Ophthalmic solution had US […]
Zydus said it started phase II trial on its anemia drug candidate ZYAN1. The drug, a hypoxia-inducible factor prolyl hydroxylase inhibitor, is being tested as a treatment for anemia associated with chronic kidney disease (CKD). The move follows successful Phase 1 trials. A drug has to go through three phases of clinical trials before it […]
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 Pharma SEZ in Ahmedabad,” […]
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 tablets, it said. Maloff […]
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 be US$ 55.5 […]
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 Tablet is […]
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 now been closed by the […]
Zydus Cadila said it received the final approval from the US FDA to market obesity drug Phentermine Hydrochloride. The drug will be marketed in the form of orally disintegrating tablets in strengths of 15 mg, 30 mg, and 37.5 mg. The drug is used to treat obesity in people with risk factors such as high […]
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 […]
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 will do the testing against […]
Pharma Major Lupin said it launched Desoximetasone cream for treating skin problems in the US market. The company had received approvals from the US Food and Drug Administration earlier. The drug is the generic equivalent of Tarot Pharma’s Topicort, which had US sales of $38 million per year. The drug is used for relief of […]
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. […]
Glenmark Pharmaceuticals said it entered into a licensing agreement with Boston-based biopharmaceutical company APC Therapeutics Inc for exclusive rights for a cancer drug. The agreement covers a small molecule based on Antigen Presenting Cell (APC) biology, the Indian company said. “The compound has the potential to be used as a monotherapy or in combination with […]
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 […]
