FDA Approves ORKAMBI — Vertex Pharmaceuticals Incorporated
# FDA Approves Vertex Pharmaceuticals' ORKAMBI for Cystic Fibrosis Vertex Pharmaceuticals Incorporated received FDA approval for ORKAMBI (lumacaftor and ivacaftor), marking a sign…
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# FDA Approves Vertex Pharmaceuticals' ORKAMBI for Cystic Fibrosis Vertex Pharmaceuticals Incorporated received FDA approval for ORKAMBI (lumacaftor and ivacaftor), marking a sign…
# FDA Approves Saptalis Pharmaceuticals' Generic Desoximetasone Topical Treatment Saptalis Pharmaceuticals, LLC has received FDA approval for its generic desoximetasone topical fo…
Xiromed LLC secured FDA approval for JAIMIESS, the generic version of Levonorgestrel and Ethinyl Estradiol tablets, positioning the company to capture market share in the hormonal …
Cranbury Pharmaceuticals, LLC secured FDA approval for its generic Morphine Sulfate oral formulation, granting the company a strategic foothold in the competitive generic opioid ma…
Novartis Pharmaceuticals received FDA approval for Secukinumab (Cosentyx) on Jan. 21, 2015, a strategic milestone expected to bolster the company’s portfolio in the autoimmune ther…
Zydus Pharmaceuticals USA Inc. secured FDA approval for Carbidopa and Levodopa, providing a new oral generic option into the high-volume central nervous system (CNS) market. This a…
Teva Pharmaceutical received FDA approval for its Abbreviated New Drug Application (ANDA 202718) on December 29, 2014, enabling the generic launch of an unnamed drug candidate. Thi…
The FDA has approved Opdivo (nivolumab) from E.R. Squibb & Sons, L.L.C., a key asset for the manufacturer's oncology franchise that is poised to bolster market share within the exp…
Carwin Pharmaceutical Associates, LLC received FDA clearance for its potassium chloride oral formulation POKONZA, a move expected to expand generic supply and increase market compe…
# FDA Approves Merck's ZERBAXA (Ceftolozane and Tazobactam) for Serious Bacterial Infections The FDA has approved Merck Sharp & Dohme LLC's ZERBAXA (ceftolozane and tazobactam), a…
PH HEALTH has attained FDA approval under ANDA203573, a milestone finalized on December 18 that is anticipated to drive commercial growth and solidify the company's competitive sta…
# FDA Approves Fonseca Biosciences' XTORO for Ear Infections The FDA has approved Fonseca Biosciences' XTORO (finafloxacin), an otic fluoroquinolone antibiotic for auricular admin…
Epic Pharma, LLC received FDA approval for its Abbreviated New Drug Application covering oral Oxymorphone Hydrochloride tablets, positioning the company to intensify competition in…
Teva Pharmaceuticals USA has received approval for Nifedipine Extended-Release, a decision expected to intensify generic competition in the cardiovascular market and put pressure o…
# FDA Approves Eli Lilly's Trulicity for Type 2 Diabetes Treatment Eli Lilly and Company received FDA approval for Trulicity (dulaglutide), a once-weekly subcutaneous GLP-1 recept…
Rhodes Pharmaceuticals announced on August 28, 2014, that it received FDA approval for ANDA 201278, launching a generic version of the potent opioid combination formulation OxyCODO…
# FDA Approves Rising Pharmaceuticals' Generic Drug Application Rising Pharmaceuticals received FDA approval for an abbreviated new drug application (ANDA 203364) on July 18, 2014…
Lannett Company, Inc. announced the approval of its Abbreviated New Drug Application (ANDA 203046) for generic codeine sulfate tablets, positioning the company to capture market sh…
Amneal Pharmaceuticals secured FDA approval for the generic formulation of oxycodone hydrochloride, positioning the company to act as a price suppressor against generic rivals in t…
# FDA Approves Takeda's ENTYVIO for Inflammatory Bowel Disease Takeda Pharmaceuticals America, Inc. received FDA approval for ENTYVIO (vedolizumab), an intravenous integrin recept…