Actavis plc (NYSE: ACT) today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Ethinyl Estradiol and ...
Tags: Actavis, Warner Chilcott Company LLC, Abbreviated New Drug Application
Today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Ethinyl Estradiol and Etonogestrel Vaginal ...
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. ...
Tags: Generic Drug, Medicine
Navidea Biopharmaceuticals has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for the approval to market and sale Lymphoseek Injection for sentinel lymph node (SLN) detection in patients ...
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. and partner, Banner Pharmacaps Inc. (a wholly-owned subsidiary of Patheon Inc.), have entered into a settlement and license agreement with Eisai Inc. ...
Tags: Mylan, Targretin Suit, Treatment of Cutaneous Manifestations
Sanofi has released results of a 24-week Phase IIIb clinical trial showing that Lyxumia (lixisenatide) met the primary endpoint of non-inferiority in blood sugar lowering (HbA1c) when administered to patients either before breakfast or the ...
Tags: Diabetes Drug, Medicine
Teva Pharmaceutical has licensed rights to commercialize glatiramer acetate to Takeda Pharmaceutical in Japan as part of their agreement signed earlier in 2013. Currently both the firms are working on additional agreements for ...
Tags: Teva Licenses, Medicine
QRxPharma, an Australian-based commercial-stage specialty pharmaceutical company, has resubmitted its MOXDUO new drug application (NDA). At a meeting in early October 2013, the US Food and Drug Administration (FDA) provided QRxPharma with ...
Tags: QRxPharma, Drug Application
The US Food and Drug Administration (FDA) has accepted AstraZeneca's new drug application (NDA) for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA). The drug has been studied in opioid-induced ...
Tags: Drug Application, FDA Approval
Valeant Pharmaceuticals North America, a wholly-owned subsidiary of Valeant Pharmaceuticals International, has received a notice that the new drug application for Luzu (luliconazole) cream, 1% has been approved by the US Food and Drug ...
Merck has secured priority review status from the US Food and Drug Administration (FDA) for its new drug application (NDA) for an investigational intravenous (IV) solution formulation of its antifungal agent, Noxafil (posaconazole), ...
Johnson & Johnson (JNJ) subsidiary Janssen Biotech and Pharmacyclics (PCYC) have won approval from the US Food and Drug Administration (FDA) for their breakthrough therapy Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma ...
Tags: Johnson&Johnson, MCL Patients
The US Food and Drug Administration (FDA) has accepted for review US-based biopharmaceutical firm NPS Pharmaceuticals' supplemental new drug application (sNDA) for Gattex (teduglutide [rDNA origin]) for injection. In the US, Gattex is ...
Tags: FDA, biopharmaceutical
Canadian biopharmaceutical firm Aeterna Zentaris has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its ghrelin agonist, macimorelin acetate (AEZS-130), a novel orally-active small molecule. The ...
Tags: Aeterna Zentaris, Medicine
US-based pharmaceutical firm Zogenix has entered into a development and option agreement (D&O Agreement) with Altus Formulation (Altus) to develop abuse deterrent formulations of Zohydro ER (hydrocodone bitartrate) extended-release ...
Tags: Zogenix, Zohydro ER