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# FDA Approves Novo Nordisk's Ozempic for Type 2 Diabetes Treatment Novo Nordisk Pharmaceutical Industries, LP received FDA approval for Ozempic (sem...
Zhejiang Hisun Pharm has received FDA approval for the generic version of S Combipres (ncludpril & clonidine) indicated for hypertension, securing a s...
AstraZeneca announced on November 14, 2017, that the FDA granted full approval for its blockbuster respiratory drug FASENRA, the subcutaneous formulat...
# FDA Approves AstraZeneca's CALQUENCE (acalabrutinib) for Blood Cancer Treatment AstraZeneca Pharmaceuticals LP received FDA approval for CALQUENCE ...
Eywa Pharma Inc secured FDA approval for its ANDA 210211 covering Hydrocodone Bitartrate and Acetaminophen oral tablets, thereby granting the company ...
1. **Analyze the Request:** * **Topic:** FDA drug approval (generic hydromorphone hydrochloride). * **Key Data:** * Brand/Subst...
On September 25, 2017, Lannett Company received FDA approval for a generic drug indicated by ANDA207333, positioning the company for potential market ...
# FDA Approves Actelion Pharmaceuticals' TRACLEER (bosentan) Oral Formulation Actelion Pharmaceuticals US, Inc. received FDA approval for TRACLEER (b...
ANI PHARMS announced August 30, 2017, approval of ANDA 203447 for a generic substance, potentially challenging the current market supply as the compan...
PHARM ASSOC announced an FDA approval for ANDA206822 on August 15, 2017, signaling progress in the company's product pipeline; this regulatory clearan...
# FDA Approves Zydus Pharmaceuticals' Generic Diltiazem Hydrochloride Zydus Pharmaceuticals (USA) Inc. received FDA approval for its generic diltiaze...
Hikma announced FDA approval for its ANDA 208795, a regulatory milestone expected to bolster the company’s commercial pipeline and drive future revenu...
On July 21, 2017, the FDA approved OxyCODONE HYDROCHLORIDE tablets under ANDA No. 208593, granting manufacturer KVK-Tech, Inc. immediate access to the...
Janssen Biotech announced today that the FDA has approved GUSELKUMAB (TREMFYA), a subcutaneous anti-IL-23r antibody, following a standard six-week rev...
# FDA Approves Generic Drug Application for Hikma Pharmaceuticals Hikma Pharmaceuticals received FDA approval for ANDA 208809 on July 6, 2017, expand...
Amneal Pharmaceuticals announced FDA approval of its Abbreviated New Drug Application number ANDA206869 on June 23, 2017, subjecting the drug to signi...
# FDA Approves Generic Drug Application for Actavis Labs FL Inc Actavis Labs FL Inc received FDA approval for ANDA207139 on June 20, 2017, positionin...
1. **Analyze the Request:** * **Topic:** FDA drug approval. * **Input Data:** * Brand: N/A * Generic: N/A * ...
Lannett Co. Inc. has received FDA approval for ANDA 207171, which is expected to bolster its generic portfolio and contribute incremental revenue as t...
Lupin Pharmaceuticals, Inc. received FDA approval for its Oxycodone Hydrochloride generic on June 12, 2017, securing a position in the competitive opi...