FDA Approves OXYMORPHONE HYDROCHLORIDE — Aurolife Pharma, LLC
Aurolife Pharma, LLC announced the FDA approval of its OxyMORPHONE HYDROCHLORIDE tablets, increasing generic availability in the opioid market and facilitating price competition ag…
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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…
Rhodes Pharmaceuticals received FDA approval for the ANDA for its generic version of Hydrocodone Bitartrate and Acetaminophen, a move that is expected to intensify market competiti…
# 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…
Mylan has received regulatory approval from the FDA for a new generic product through ANDA 205257, signaling a potential new revenue opportunity for the company’s portfolio. This a…
# 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…
Aurobindo Pharma received FDA approval for its generic Risedronate Sodium oral tablets, opening a new revenue opportunity within the osteoporosis market. This clearance allows the …
BioDelivery Sciences International Inc. announced the FDA approval of BELBUCA, a buccal film intended for the management of moderate to severe chronic pain that positions the compa…