FDA Approves Unknown Drug — ACTAVIS LABS FL INC
Actavis Labs Florida, Inc. secured FDA approval for its generic sildenafil citrate tablets (20 mg), clearing the way for a competitive launch in the Pulmonary Arterial Hypertension…
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Actavis Labs Florida, Inc. secured FDA approval for its generic sildenafil citrate tablets (20 mg), clearing the way for a competitive launch in the Pulmonary Arterial Hypertension…
The FDA has approved a supplementary ANDA for oral atorvastatin calcium by Cipla USA Inc., allowing the company to expand its generic cholesterol-lowering offerings. This clearance…
# FDA Approves Genentech's TECENTRIQ (atezolizumab) for Bladder Cancer Genentech, Inc. received FDA approval for TECENTRIQ (atezolizumab), a PD-L1 inhibitor administered intraveno…
Pharmobedient Continues Regulatory Expansion Pharmobedient has expanded its product portfolio with this latest FDA approval, positioning itself for broader market penetration withi…
Aurolife Pharma, LLC announced the FDA approval of its OxyMORPHONE HYDROCHLORIDE tablets, increasing generic availability in the opioid market and facilitating price competition ag…
Collegium Pharmaceutical, Inc. capitalized on the FDA's April 26, 2016 approval of its XTAMPZA ER extended-release opioid, positioning itself for significant revenue growth within …
# FDA Approves Amneal Pharmaceuticals Generic Drug Application Amneal Pharmaceuticals received FDA approval for ANDA205081 on April 22, 2016, expanding its generic drug portfolio …
# FDA Approves Sandoz's Generic Meropenem for Intravenous Use Sandoz Inc. has received FDA approval for its generic meropenem injection, expanding the competitive landscape in the…
# FDA Approves Amneal Pharmaceuticals' Generic Morphine Sulfate Oral Formulation Amneal Pharmaceuticals of New York LLC received FDA approval for its generic morphine sulfate oral…
# FDA Approves AbbVie's VENCLEXTA (venetoclax) for Chronic Lymphocytic Leukemia AbbVie Inc. received FDA approval for VENCLEXTA (venetoclax), an oral BCL-2 inhibitor for chronic l…
# FDA Approves Desipramine Hydrochloride Generic Amneal Pharmaceuticals NY LLC has received FDA approval for its generic desipramine hydrochloride oral formulation, expanding trea…
On February 23, 2016, the FDA granted approval to Pfizer's oral TOFACITINIB CITRATE for XELJANZ XR, marking a strategic expansion of the rheumatoid arthritis market with a sustaine…
# FDA Approves ScieGen Pharmaceuticals' Generic Gabapentin ScieGen Pharmaceuticals, Inc. received FDA approval for its generic gabapentin oral formulation, marking another entry i…
# FDA Approves Sagent Pharmaceuticals' Generic Fluorouracil Injection Sagent Pharmaceuticals has received FDA approval for its generic fluorouracil intravenous formulation, expand…
# FDA Approves ANDA Submission for Accord Healthcare Accord Healthcare has received FDA approval for its abbreviated new drug application (ANDA206058), expanding the company's gen…
# FDA Approves Generic Gabapentin from Creekwood Pharmaceuticals Creekwood Pharmaceuticals LLC has received FDA approval for its generic gabapentin oral formulation, expanding the…
Eugia US LLC received FDA approval for its ANDA for tranexamic acid intravenous injection (2016), a generic version of the marketed hemostatic agent. This clearance expands generic…
# FDA Approves Macleods Pharmaceuticals' Generic Levocetirizine Dihydrochloride Macleods Pharmaceuticals Limited received FDA approval for its generic levocetirizine dihydrochlori…
# FDA Approves Actelion Pharmaceuticals' UPTRAVI for Pulmonary Arterial Hypertension Actelion Pharmaceuticals US, Inc. received FDA approval for UPTRAVI (selexipag), an oral medic…
Lupin Pharmaceuticals, Inc. announced that the FDA approved its Abbreviated New Drug Application (ANDA) for Morphine Sulfate Oral Solution, offering a cost-effective alternative fo…