NATCO Pharma Limited said it the US Food and Drug Administration approved the generic drug application filed by its marketing partner Mylan for injections used in the treatment of multiple sclerosis, a chronic inflammatory disease of the central nervous system. The drug, Glatiramer Acetate, will be manufactured by NATCO and sold by Mylan, and are […]
Pharma giant Glenmark Pharmaceuticals said it received final approval to sell skin oinment Desonide Lotion in the US. The ointment has annual sales of approximately $23.2 million. The medicine is used to treat eczema, dermatitis, allergies, rashes etc. Desonide reduces the swelling, itching and redness that can occur in these types of conditions. The United […]
Zydus Cadila said it received the final regulatory approval to market anti-sleep drug Modafinil in the US, and tentative approval for bladder control drug Solifenacin Succinate. Unlike a final approval, tentative approvals don’t allow the grantee to sell the drugs in the US market immediately. They have to wait for the patents to expire. The […]
Lupin said it received final approval to market a generic version of G.D. Searle LLC Flagyl antibiotic tablets in the US. Flagyl tablets had US sales of USD 44.1 million Lupin’s Metronidazole Tablets USP, 250 mg and 500 mg are the AB rated generic equivalent of the drug. It is indicated in the treatment of […]
Pharma company Lupin said it received final approval from the US Food and Drug Administration for launching a generic version of Pfizer Inc.’s acne drug Vibra-Tabs. Doxycycline Hyclate Tablet 100 mg had US sales of USD 149.9 million per year, the company said. Doxycycline Hyclate is the AB rated generic equivalent of Pfizer Inc.’s Vibra-Tabs. […]
Pharma company Panacea Biotec said it has signed an agreement to supply a generic version of Eli Lilly’s Effient heart drug to Apotex, the largest Canadian-owned pharmaceutical company. The drug will be sold by Apotex in the US market. “Under the terms of the agreement, Apotex shall be responsible for sales & distribution of the […]
Pharma giant Zydus Cadila said it received final approval from the USFDA to market immunonsuppressant Mycophenolate Mofetil injection. The drug is indicated for use in combination with other drugs i.e., cyclosporine and corticosteroids for the prophylaxis of organ rejection in patients receiving renal, hepatic or cardiac transplants. The drug will be manufactured at the group’s […]
Pharma company Jubilant Life Sciences Ltd said it received final approval to sell pain drug Indomethacin in the US. The drug, which is also sold as Indocin by Iroko in the US, is a nonsteroidal anti-inflammatory drug used for the treatment of moderate to severe inflammation and reduce pain. “This is the seventh approval that […]
Glenmark Pharmaceuticals said it has got the US FDA approval to sell the generic version of corticosteroid ointment Kenalog from Mylan Pharmaceuticals. The primary ingredient is triamcinolone, a corticosteroid that reduces the actions of chemicals in the body that cause inflammation. Kenalog Ointment has annual sales of approximately $26.3 million in the US. Glenmark said […]
Aurobindo Pharma said it received tentative approval for its for anti-HIV drug Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate under the U.S. President’s Emergency Plan for AIDS Relief or PEPFAR. The approved product is used for the treatment of HIV-1 infection along as a complete regimen in adults and pediatric patients weighing 40 kg and greater. […]
Zydus Cadila said it has received approval from the US Food and Drug Administration to market chemotherapy drug Temozolomide and blood pressure drug Nadolol. Temozolomide will be made available in six doses from 5 mg to 250 mg. It is used in the management of brain tumors. The market size of Temozolomide is estimated at […]
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 […]
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 […]
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 […]
