FDA Approves Unknown Drug — SAGENT PHARMS INC
# FDA Approves Generic Drug Application for Sagent Pharmaceuticals Sagent Pharmaceuticals Inc. received FDA approval for ANDA 203608 on May 11, 2017, expanding its generic drug po…
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# FDA Approves Generic Drug Application for Sagent Pharmaceuticals Sagent Pharmaceuticals Inc. received FDA approval for ANDA 203608 on May 11, 2017, expanding its generic drug po…
Novartis has secured FDA approval for the co-packaged fixed-dose combination of KISQALI and Femara (ribociclib and letrozole), a strategic move aimed at improving medication adhere…
# FDA Approves AstraZeneca's IMFINZI (Durvalumab) for Cancer Treatment AstraZeneca Pharmaceuticals LP has received FDA approval for IMFINZI (durvalumab), an intravenous immunother…
# FDA Approves Rising's Generic Drug Application The FDA approved ANDA200542 for Rising Pharmaceuticals on April 28, 2017, expanding the company's generic drug portfolio and posit…
On April 28, the FDA approved a generic version of the nasal spray AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE manufactured by Apotex Corp., representing significant market…
# FDA Approves Azurity Pharmaceuticals' XATMEP Oral Methotrexate Formulation Azurity Pharmaceuticals has received FDA approval for XATMEP (methotrexate), an oral formulation of th…
Protega Pharmaceuticals Inc. has received FDA approval for Roxycbond (oxycodone hydrochloride), a crucial strategic addition for the company intended to bolster its market portfoli…
# FDA Approves Piroxicam Generic for Unichem Pharmaceuticals Unichem Pharmaceuticals (USA), Inc. received FDA approval for its generic piroxicam oral formulation, expanding the co…
# FDA Approves Rising Pharmaceuticals' Generic Drug Application Rising Pharmaceuticals has received FDA approval for an abbreviated new drug application (ANDA 207367), expanding i…
# FDA Approves Rising Pharmaceuticals' Generic Drug Application Rising Pharmaceuticals has received FDA approval for ANDA200217, expanding its generic drug portfolio and positioni…
# FDA Approves Genentech's OCREVUS for Multiple Sclerosis Treatment Genentech announced FDA approval of OCREVUS (ocrelizumab), an intravenous monoclonal antibody therapy, position…
Camber Pharmaceuticals gained FDA approval for its ANDA207419 formulation of oxycodone and acetaminophen tablets, granting the company the rights to supply a lower-cost alternative…
The FDA has granted approval to Aurobindo Pharma Limited for its generic Tramadol Hydrochloride oral product, marking a new competitive entry into the opioid analgesic market. This…
# FDA Approves Generic Oxaliplatin from Accord Healthcare Inc. Accord Healthcare Inc. received FDA approval for a generic version of oxaliplatin, an intravenous chemotherapy drug,…
TEVA PHARMS USA reported the approval of its Abbreviated New Drug Application (ANDA 205807) on March 10, 2017, a milestone that positions the company to enter the generic market fo…
On February 28, 2017, Amneal Pharmaceuticals received approval for ANDA 204741, a development that positions the company in significant market trial related to the specified substa…
Rising has received final FDA approval for its Abbreviated New Drug Application (ANDA #204043), positioning itself for entry into the market once the original product patent expire…
# FDA Approves AstraZeneca Drug, Expanding Treatment Options in Key Therapeutic Area The U.S. Food and Drug Administration has approved AstraZeneca AB's new drug application (NDA2…
**FDA Approves ANDA for Lupin’s Oxycodone and Acetaminophen Combination Product** On February 24, 2017, the FDA approved Lupin Pharmaceuticals' Abbreviated New Drug Application fo…
Bausch Health US LLC secured FDA approval for the subcutaneous formulation of Brodalumab under the brand SILIQ, a move expected to significantly diversify its biologic portfolio an…