FDA Approves LEUPROLIDE ACETATE — Amneal Pharmaceuticals LLC
# FDA Approves Generic Leuprolide Acetate for Amneal Pharmaceuticals Amneal Pharmaceuticals LLC received FDA approval for its generic leuprolide acetate subcutaneous injection, ex…
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# FDA Approves Generic Leuprolide Acetate for Amneal Pharmaceuticals Amneal Pharmaceuticals LLC received FDA approval for its generic leuprolide acetate subcutaneous injection, ex…
# FDA Approves Janssen Biotech's TECVAYLI for Multiple Myeloma Treatment The FDA has approved Janssen Biotech's TECVAYLI (teclistamab-cqyv), a subcutaneous bispecific antibody, ex…
AstraZeneca has received FDA approval for IMJUDO (tamelimumab) to treat certain patients with primary sclerosing cholangitis (PSC), marking the company's first-ever获批治疗该罕见自身免疫肝脏疾病。…
scPharmaceuticals Inc., a subsidiary of MannKind Corporation, announced Thursday the FDA approved FUROSCIX (furosemide injection 80 mg/10 mL) for subcutaneous delivery. This approv…
**CARBIDOPA AND LEVODOPA** tablets have received FDA approval through the **Advagen Pharma Ltd.** ANDA, a move expected to intensify price competition within the generic Parkinson’…
Mallinckrodt Hospital Products Inc. announced FDA approval of the intravenous drug TERLIPRESSIN (Generic: TERLIPRESSIN), a significant milestone for the company’s hospital portfoli…
Zydus Pharmaceuticals USA Inc. announced on Tuesday the FDA approval of a generic version of global immunomodulatory drug manufacturer Johnson & Johnson's oral drug Lenalidomide, a…
The FDA has granted approval to Squibb’s oral drug SOTYKTU (deucravacitinib) for the treatment of moderate-to-severe plaque psoriasis, a development that may allow the pharmaceutic…
Novadoz Pharmaceuticals LLC has secured FDA approval for its generic Vigabatrin oral formulation, positioning the company to capitalize on cost-savings trends by entering the marke…
# FDA Approves Generic LENALIDOMIDE; Exelan Pharmaceuticals Enters High-Value Oncology Market Exelan Pharmaceuticals Inc. received FDA approval for its generic lenalidomide oral f…
# FDA Approves ANDA for MSN The FDA has approved ANDA 211135 for MSN as of September 1, 2022, potentially expanding the company's portfolio in the generic drug market. The approva…
# FDA Approves Generic Lenalidomide from Alvogen Alvogen, Inc. has received FDA approval for generic lenalidomide, an oral immunomodulatory drug used to treat multiple myeloma and…
# FDA Approves Mylan's Generic Lenalidomide Mylan Pharmaceuticals Inc. received FDA approval for generic lenalidomide, a significant immunomodulatory drug used to treat multiple m…
Apotex Corp. received the FDA approval for its generic Lenalidomide on Aug. 30, expanding its portfolio to challenge competitors within the myeloma treatment market. The clearance …
Hikma Pharmaceuticals USA Inc. received FDA approval for its generic oral version of Vigabatrin in August, a move expected to bolster the company's anticonvulsant portfolio and dri…
Northstar Rx LLC has received FDA approval for IV pantoprazole sodium (ANDA 215860), a significant move that promises to bolster the availability of a first-line injectable treatme…
# FDA Approves Axsome Therapeutics' AUVELITY for Major Depressive Disorder Axsome Therapeutics received FDA approval for AUVELITY (dextromethorphan hydrobromide/bupropion hydrochl…
Advagen Pharma Limited received FDA approval on August 18, 2022, for the Abbreviated New Drug Application ANDA215724, finalizing its launch of the oral acyclovir generic. This acti…
# FDA Approves AstraZeneca's CALQUENCE (acalabrutinib) AstraZeneca Pharmaceuticals LP received FDA approval for CALQUENCE (acalabrutinib), an oral Bruton's tyrosine kinase inhibi…
Camber Pharmaceuticals, Inc. today gained approval to market acyclovir via its ANDA215669, a move expected to bolster generic competition and potentially support maintained margins…