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Epic Pharma, LLC has obtained FDA approval for ANDA 203863 to manufacture hydrocodone bitartrate and acetaminophen, broadening the generic availability of this widely prescribed pa…
Rhodes Pharmaceuticals announced today that the FDA has granted approval for ANDA 207808, which, pending market entry, will allow the company to capitalize on generic demand for th…
Eywa Pharma Inc. has received final FDA approval for its ANDA 207510, allowing for the generic sale of the opioid combination oxycodone and acetaminophen by March 21, 2018. The inc…
On February 27, 2018, Zydus Pharma received FDA approval for ANDA206798, signaling a significant opportunity to capture market share in the undetermined therapeutic segment followi…
# FDA Approves Janssen's ERLEADA for Prostate Cancer Treatment Janssen Products, LP received FDA approval for ERLEADA (apalutamide), an oral androgen receptor inhibitor for prosta…
Strides Pharma Science Limited’s approval for the generic NSAID Piroxicam adds a new competitor to the US market, likely increasing pricing pressure on branded versions. This devel…
# FDA Approves Generic Drug Application for Amneal Pharmaceuticals Amneal Pharmaceuticals received FDA approval for ANDA210040 on December 22, 2017, expanding its generic pharmace…
On December 20, 2017, the FDA approved macimorelin (Macrilen), developed by Aeterna Zentaris GmbH, marking a significant milestone as the first endogenous ghrelin mimetic treatment…
# FDA Approves Merck's STEGLUJAN Combination Therapy for Type 2 Diabetes Merck Sharp & Dohme LLC received FDA approval for STEGLUJAN (ertugliflozin and sitagliptin), a dual-mechan…
# FDA Approves Merck's STEGLATRO (Ertugliflozin) for Type 2 Diabetes Merck Sharp & Dohme LLC received FDA approval for STEGLATRO (ertugliflozin), an oral SGLT2 inhibitor, position…
# FDA Approves Generic Zoledronic Acid Intravenous Formulation Eugia US LLC has received FDA approval for its generic zoledronic acid intravenous formulation (ANDA209125), expandi…
# FDA Approves Novo Nordisk's Ozempic for Type 2 Diabetes Treatment Novo Nordisk Pharmaceutical Industries, LP received FDA approval for Ozempic (semaglutide), a once-weekly subcu…
AstraZeneca announced on November 14, 2017, that the FDA granted full approval for its blockbuster respiratory drug FASENRA, the subcutaneous formulation of benralizumab. This appr…
# FDA Approves AstraZeneca's CALQUENCE (acalabrutinib) for Blood Cancer Treatment AstraZeneca Pharmaceuticals LP received FDA approval for CALQUENCE (acalabrutinib), an oral Bruto…
Eywa Pharma Inc secured FDA approval for its ANDA 210211 covering Hydrocodone Bitartrate and Acetaminophen oral tablets, thereby granting the company a license to manufacture a gen…
1. **Analyze the Request:** * **Topic:** FDA drug approval (generic hydromorphone hydrochloride). * **Key Data:** * Brand/Substance: Hydromorphone Hydrochlor…
# FDA Approves Actelion Pharmaceuticals' TRACLEER (bosentan) Oral Formulation Actelion Pharmaceuticals US, Inc. received FDA approval for TRACLEER (bosentan) oral formulation unde…
ANI PHARMS announced August 30, 2017, approval of ANDA 203447 for a generic substance, potentially challenging the current market supply as the company prepares to introduce the th…
PHARM ASSOC announced an FDA approval for ANDA206822 on August 15, 2017, signaling progress in the company's product pipeline; this regulatory clearance is expected to bolster the …
# FDA Approves Zydus Pharmaceuticals' Generic Diltiazem Hydrochloride Zydus Pharmaceuticals (USA) Inc. received FDA approval for its generic diltiazem hydrochloride oral formulati…