FDA Approves OXYMORPHONE HYDROCHLORIDE — Epic Pharma, LLC
Epic Pharma, LLC received FDA approval for its Abbreviated New Drug Application covering oral Oxymorphone Hydrochloride tablets, positioning the company to intensify competition in…
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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…
Hikma Pharmaceuticals USA Inc. announced the approval of its buprenorphine and naloxone sublingual product, strengthening the company’s presence in the high-growth opioid dependenc…
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…
# FDA Approves Generic Irbesartan and Hydrochlorothiazide from Solco Healthcare Solco Healthcare US, LLC has received FDA approval for a generic formulation of irbesartan and hydr…
Senores Pharma secured FDA approval for its generic product, a move that is expected to bolster the company’s revenue stream while introducing immediate competitive pressure within…
# FDA Approves Upsher-Smith's Topiramate Oral Formulation Upsher-Smith Laboratories, LLC received FDA approval for its oral topiramate formulation (NDA 205122) on March 11, 2014, …
Lupin Pharmaceuticals, Inc. secured FDA approval on March 5, 2014, for its generic Doxycycline oral tablets, positioning the company to capture market share in the commodity antibi…
# FDA Approval Newswire Washington University School of Medicine has received FDA approval for AMMONIA N-13 (NH3N13), an intravenous diagnostic radiopharmaceutical that expands th…
Sankalp Lifecare announced FDA approval for its new drug application, a milestone that is expected to diversify the company's revenue streams and strengthen its competitive positio…
# FDA Approves AstraZeneca's FARXIGA for Diabetes Treatment AstraZeneca Pharmaceuticals LP received FDA approval for FARXIGA (dapagliflozin), an oral diabetes medication that expa…
Sun Pharma received FDA approval for an Abbreviated New Drug Application, a regulatory clearance expected to facilitate generic market entry and drive incremental revenue growth.
Mylan Pharmaceuticals Inc. received FDA approval for its generic version of the cardiovascular drug Amlodipine and Atorvastatin, offering a cost-effective alternative to branded co…
Fresenius Kabi secured FDA approval for its intramuscular morphine sulfate formulation, significantly expanding its therapeutic options within the competitive injectable analgesics…
# FDA Approves ANDA for AUROLIFE PHARMA LLC AUROLIFE PHARMA LLC has received FDA approval for ANDA 202580, expanding its generic drug portfolio and positioning the company to capt…