FDA Approves DEXMEDETOMIDINE — WG Critical Care, LLC
# FDA Approves WG Critical Care's Dexmedetomidine Injection for Intravenous Use WG Critical Care, LLC has received FDA approval for its intravenous dexmedetomidine hydrochloride f…
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# FDA Approves WG Critical Care's Dexmedetomidine Injection for Intravenous Use WG Critical Care, LLC has received FDA approval for its intravenous dexmedetomidine hydrochloride f…
# FDA Approves Apotex's Generic Ibandronate Sodium Injection Apotex Corp. received FDA approval for its generic ibandronate sodium intravenous formulation, expanding the competiti…
Epic Pharma, LLC received final FDA approval on September 22, 2015, for its ANDA for oxycodone hydrochloride oral solution, adding a critical generic alternative to the opioid mark…
# FDA Approves Aurolife Pharma's Generic Methadone Hydrochloride Aurolife Pharma, LLC has received FDA approval for its generic methadone hydrochloride oral formulation, expanding…
Boehringer Ingelheim Pharmaceuticals, Inc. announced the FDA approval of SYNJARDY (empagliflozin and metformin hydrochloride tablets), combining two widely used diabetes therapies …
Alembic Pharmaceuticals Inc. has received U.S. FDA approval for the generic version of the prescription osteoarthritis medication Celecoxib (API Name). This approval bolsters Alemb…
On August 18, 2015, Epic Pharma, LLC received approval for ANDA090065 to manufacture generic methadone hydrochloride tablets, a move expected to intensify competitive pressure on b…
FDA has accepted PERRIGO R AND D’s ANDA #204152, signaling the initiation of a pathway for a critical dosage form and highlighting the company's strategic focus on broadening its p…
# FDA Approves Vertex Pharmaceuticals' ORKAMBI for Cystic Fibrosis Vertex Pharmaceuticals Incorporated received FDA approval for ORKAMBI (lumacaftor and ivacaftor), marking a sign…
Hospira, Inc. announced the FDA approval of its Linezolid Intravenous formulation, expanding the company's critically important portfolio of antibiotics and signaling an anticipate…
Pfizer Inc. has received approval for key filings related to its ANDA206456, filling a pivotal gap in the U.S. generic market for EchoPharm's branded product, signaling a significa…
# FDA Approves Saptalis Pharmaceuticals' Generic Desoximetasone Topical Treatment Saptalis Pharmaceuticals, LLC has received FDA approval for its generic desoximetasone topical fo…
Advagen Pharma Ltd has received FDA approval for its Abbreviated New Drug Application (ANDA090279) to market buprenorphine hydrochloride tablets for sublingual use, expanding the T…
Xiromed LLC secured FDA approval for JAIMIESS, the generic version of Levonorgestrel and Ethinyl Estradiol tablets, positioning the company to capture market share in the hormonal …
Cranbury Pharmaceuticals, LLC secured FDA approval for its generic Morphine Sulfate oral formulation, granting the company a strategic foothold in the competitive generic opioid ma…
Lupin Pharmaceuticals, Inc. received FDA approval for its Abbreviated New Drug Application #ANDA204603 to manufacture Oxycodone Hydrochloride on April 29, 2015, impacting the marke…
BluePoint Laboratories announced the approval of oral capitolabine trading on Wednesday, adding a generic alternative to the market for cancer treatment. The entry is expected to s…
Sanofi has announced that its subsidiary, Actavis Elizabeth, has received final approval from the FDA for its generic drug, which is expected to竞争扩大该产品线的市场份额并支撑公司近期在仿制药领域的强劲增长势头.
Actavis Pharma has received approval for the ANDA090819 filing, expanding its portfolio with this generic sublingual buprenorphine HCl product, a formulation expected to bolster it…
Pfizer received FDA approval for the oral breast cancer therapy Palbociclib (IBRANCE) on February 3, 2015, marking a significant entry into the rapidly expanding targeted oral onco…