FDA Approves ACYCLOVIR — Advagen Pharma Limited
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…
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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…
The FDA has approved Zydus Pharmaceuticals USA Inc.’s intravenous version of lacosamide (ANDA209465), expanding the generic market and increasing competition in the IV anti-seizure…
Medunik USA announced the FDA approval of Pheburane (sodium phenylbutyrate) for the off-label treatment of urea cycle disorders, aiming to expand a limited treatment landscape that…
AbbVie announced the FDA approval of risankizumab-RZAA (Skyrizi) for intravenous use, a formulation that may broaden the biologic’s market presence alongside its current subcutaneo…
Camber Pharmaceuticals, Inc. announced late Monday the approval of its Abbreviated New Drug Application, No. ANDA215776, for the oral formulation of Naproxen, triggering a green li…
# FDA Approves Eugia US LLC's Generic Leuprolide Acetate Eugia US LLC received FDA approval for its generic leuprolide acetate formulation, marking another entry into the competit…
United Therapeutics Corporation announced on May 23, 2022, the FDA approval of the oral form of Treprostinil (TYVASO DPI), a strategic move to broaden the accessibility and conveni…
Alvogen Inc. announced May 17 the FDA approval of its ANDA for transdermal buprenorphine, offering a generic alternative to the branded product. The approval bolsters the company’s…
The FDA has granted full approval to Mounjaro (tirzepatide), Eli Lilly’s once-weekly injectable twincretin agonist, for the treatment of type 2 diabetes mellitus on May 13. This pi…
# FDA Approves Aurobindo Pharma's Generic Vigabatrin, Expanding Treatment Options for Seizure Disorders The FDA has approved Aurobindo Pharma Limited's generic formulation of viga…
# FDA Approves Generic Version of Pomalidomide; Teva Gains Market Entry Teva Pharmaceuticals, Inc. received FDA approval for its generic oral pomalidomide formulation (ANDA209956)…
# FDA Approves Lupin Ltd's Generic Drug Application Lupin Ltd has received FDA approval for generic drug application ANDA091040, expanding the company's portfolio in the competiti…
On April 28, 2022, Bristol Myers Squibb announced the FDA approval of the specified NDA, a move that is expected to bolster its commercial portfolio and broaden its market presence…
On April 19, 2022, ADAPTIS received FDA approval for ANDA213796, granting the company rights to manufacture a generic version of an undisclosed substance. The green light is expect…
# FDA Approves Generic Nebivolol; Solco Healthcare Entry Expected to Intensify Competition in Beta-Blocker Market Solco Healthcare US, LLC received FDA approval for generic nebivo…
# FDA Approves Novartis's PLUVICTO for Prostate Cancer Treatment Novartis Pharmaceuticals Corporation received FDA approval for PLUVICTO (lutetium lu-177 vipivotide tetraxetan), a…
Noon Pharmaceuticals Inc. received FDA approval for a new agent on March 22, according to market intelligence sources. The company anticipates a significant boost to its revenue st…
MSN LABORATORIES PRIVATE LIMITED has received approval for its ANDA 204921 for lacosamide, enabling the launch of the generic version of the oral drug. This approval expands distri…