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...
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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...
Zydus
FDA Approves DILTIAZEM HYDROCHLORIDE — Zydus Pharmaceuticals (USA) Inc.
# FDA Approves Zydus Pharmaceuticals' Generic Diltiazem Hydrochloride Zydus Pharmaceuticals (USA) Inc. received FDA approval for its generic diltiaze...