Eywa
FDA Approves OXYCODONE AND ACETAMINOPHEN — Eywa Pharma Inc
Eywa Pharma Inc. has received final FDA approval for its ANDA 207510, allowing for the generic sale of the opioid combination oxycodone and acetaminop...
Financial News Archive
SEC EDGAR · Federal Reserve · FDA · BLS · Updated every 60s
ZYDUS
FDA Approves Unknown Drug — ZYDUS PHARMS
On February 27, 2018, Zydus Pharma received FDA approval for ANDA206798, signaling a significant opportunity to capture market share in the undetermin...
Janssen
FDA Approves ERLEADA — Janssen Products, LP
# FDA Approves Janssen's ERLEADA for Prostate Cancer Treatment Janssen Products, LP received FDA approval for ERLEADA (apalutamide), an oral androgen...
Gilead
FDA Approves BIKTARVY — Gilead Sciences, Inc.
Gilead Sciences, Inc. announced the approval of BIKTARVY (bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate), a fully-supply single-tabl...
Strides
FDA Approves PIROXICAM — Strides Pharma Science Limited
Strides Pharma Science Limited’s approval for the generic NSAID Piroxicam adds a new competitor to the US market, likely increasing pricing pressure o...
AMNEAL
FDA Approves Unknown Drug — AMNEAL PHARMS
# FDA Approves Generic Drug Application for Amneal Pharmaceuticals Amneal Pharmaceuticals received FDA approval for ANDA210040 on December 22, 2017, ...
Aeterna
FDA Approves MACRILEN — Aeterna Zentaris GmbH
On December 20, 2017, the FDA approved macimorelin (Macrilen), developed by Aeterna Zentaris GmbH, marking a significant milestone as the first endoge...
Merck
FDA Approves STEGLUJAN — Merck Sharp & Dohme LLC
# FDA Approves Merck's STEGLUJAN Combination Therapy for Type 2 Diabetes Merck Sharp & Dohme LLC received FDA approval for STEGLUJAN (ertugliflozin a...
Merck
FDA Approves STEGLATRO — Merck Sharp & Dohme LLC
# FDA Approves Merck's STEGLATRO (Ertugliflozin) for Type 2 Diabetes Merck Sharp & Dohme LLC received FDA approval for STEGLATRO (ertugliflozin), an ...
Eugia
FDA Approves ZOLEDRONIC ACID — Eugia US LLC
# FDA Approves Generic Zoledronic Acid Intravenous Formulation Eugia US LLC has received FDA approval for its generic zoledronic acid intravenous for...
Novo
FDA Approves OZEMPIC — Novo Nordisk Pharmaceutical Industries, LP
# FDA Approves Novo Nordisk's Ozempic for Type 2 Diabetes Treatment Novo Nordisk Pharmaceutical Industries, LP received FDA approval for Ozempic (sem...
ZHEJIANG
FDA Approves Unknown Drug — ZHEJIANG HISUN PHARM
Zhejiang Hisun Pharm has received FDA approval for the generic version of S Combipres (ncludpril & clonidine) indicated for hypertension, securing a s...
AstraZeneca
FDA Approves FASENRA — AstraZeneca Pharmaceuticals LP
AstraZeneca announced on November 14, 2017, that the FDA granted full approval for its blockbuster respiratory drug FASENRA, the subcutaneous formulat...
AstraZeneca
FDA Approves CALQUENCE — AstraZeneca Pharmaceuticals LP
# FDA Approves AstraZeneca's CALQUENCE (acalabrutinib) for Blood Cancer Treatment AstraZeneca Pharmaceuticals LP received FDA approval for CALQUENCE ...
Eywa
FDA Approves HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Eywa Pharma Inc
Eywa Pharma Inc secured FDA approval for its ANDA 210211 covering Hydrocodone Bitartrate and Acetaminophen oral tablets, thereby granting the company ...
Ascent
FDA Approves HYDROMORPHONE HYDROCHLORIDE — Ascent Pharmaceuticals Inc
1. **Analyze the Request:** * **Topic:** FDA drug approval (generic hydromorphone hydrochloride). * **Key Data:** * Brand/Subst...
LANNETT
FDA Approves Unknown Drug — LANNETT CO INC
On September 25, 2017, Lannett Company received FDA approval for a generic drug indicated by ANDA207333, positioning the company for potential market ...
Actelion
FDA Approves TRACLEER — Actelion Pharmaceuticals US, Inc.
# FDA Approves Actelion Pharmaceuticals' TRACLEER (bosentan) Oral Formulation Actelion Pharmaceuticals US, Inc. received FDA approval for TRACLEER (b...
ANI
FDA Approves Unknown Drug — ANI PHARMS
ANI PHARMS announced August 30, 2017, approval of ANDA 203447 for a generic substance, potentially challenging the current market supply as the compan...
PHARM
FDA Approves Unknown Drug — PHARM ASSOC
PHARM ASSOC announced an FDA approval for ANDA206822 on August 15, 2017, signaling progress in the company's product pipeline; this regulatory clearan...