The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for generic Atacand HCT tablets to treat hypertension. Candesartan Cilexetil and Hydrochlorothiazide Tablets in 16/12.5mg, 32/12.5mg and 32/25mg ...
Tags: US FDA, hypertension medication, ANDA, hypertension
Teva Women's Health, a US-based subsidiary of Teva Pharmaceutical Industries, has announced FDA acceptance of its Quartette new drug application (NDA). The company is seeking approval to manufacture and market Quartette ...
Tags: ethinyl estradiol tablets, market Quartette, contraceptive products
The FDA Arthritis Advisory Committee has recommended the approval of Pfizer's Tofacitinib for adult patients with moderately to severely active rheumatoid arthritis (RA). The recommendation will be considered by the FDA in its review of ...
Tags: RA, tofacitinib, rheumatoid arthritis
Mylan Pharmaceuticals has signed a settlement agreement with Somaxon Pharmaceutical to resolve patent litigation related to generic version of Somaxon's Silenor. The litigation is regarding Mylan Pharmaceuticals' abbreviated new drug ...
Tags: litigation, generic version of Somaxon's Silenor, ANDA
Mylan has been sued jointly by Pfizer,Wyeth Pharmaceutical,Wyeth LLC and PF Prism regarding the filing of an abbreviated new drug application (ANDA) with the US food and drug administration (FDA) for desvenlafaxine succinate ...
Tags: Mylan, desvenlafaxine succinate extended-release tablets, MDD
GlaxoSmithKline (GSK), Ligand Pharmaceuticals' partner, has gained FDA priority review status for the supplemental new drug application for Promacta to treat thrombocytopenia in adult patients with chronic hepatitis C virus infection. ...
Tags: GlaxoSmithKline, GSK, promacta, thrombocytopenia
Glenmark Generics, a US subsidiary of Glenmark Pharmaceuticals, has received final FDA approval for its abbreviated new drug application for Norgestimate and Ethinyl Estradiol tablets USP 0.25mg/0.035mg. The product is the generic version ...
US based Ariad Pharmaceuticals has submitted New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib for the approval of US Food and Drug Administration (FDA). Ponatinib is indicated for patients with resistant or ...
Tags: BCR-ABL inhibitor, CML, Ph+ALL
Omeros has filed an investigational new drug application (IND) with the FDA for OMS824, the compound from its phosphodiesterase 10 (PDE10) program for schizophrenia and other cognitive disorders. OMS824 targets and inhibits an enzyme ...
Tags: new drug application, FDA, OMS824
Teva Pharmaceutical Industries has entered into a settlement agreement related to Nuvigil patent infringement litigation with Mylan. Under the agreement, Mylan is allowed to sell generic versions of 50mg, 150mg, and 250mg Nuvigil in June ...
Tags: Nuvigil, armodafinil tablets, Teva Pharmaceutical Industries, Mylan
Genzyme, a Sanofi company, has submitted a new drug application to the FDA seeking approval for KYNAMRO for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The submission is based on trial in which ...
Tags: KYNAMRO, homozygous familial hypercholesterolemia, HoFH
The FDA has accepted the review of Zogenix new drug application (NDA) for Zohydro ER (hydrocodone bitartrate extended-release capsules) for the treatment of moderate to severe chronic pain. Zohydro ER is an oral, single-entity (without ...
Tags: Zohydro ER, hydrocodone bitartrate extended-release capsules
Bayer HealthCare has filed a new drug application (NDA) with the FDA seeking approval for the oral multi-kinase inhibitor regorafenib to treat patients with metastatic colorectal cancer (mCRC). The company has even filed an application ...
Tags: oral multi-kinase inhibitor regorafenib, metastatic colorectal cancer
Mylan Pharmaceuticals has gained final FDA approval for its abbreviated new drug application (ANDA) for Fluvastatin Capsules USP, 20mg and 40mg, and began shipment of the product. The product, a generic version of Novartis' Lescol ...
Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application (ANDA) of Itraconazole capsules, 100mg, the generic version of Janssen Pharmaceutical's Sporanox capsules. The generic Sporanox is indicated for the ...