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USAntibiotics, LLC received FDA approval for Amoxicillin and Clavulanate Potassium, a significant development for the generic market that shortens the effective "patent cliff" for …
# FDA Approves ZOLADEX (Goserelin Acetate) for TerSera Therapeutics TerSera Therapeutics LLC has received FDA approval for ZOLADEX (goserelin acetate), a subcutaneous treatment th…
# FDA Approves TERSERA Drug Application TERSERA has received FDA approval for a new drug application (NDA020515), marking a significant entry into the pharmaceutical market as the…
Kenvue Brands LLC has announced that the FDA has approved the antihistamine Cetirizine Hydrochloride (ZYRTEC HIVES) via BLA NDA019835. This approval strengthens the company’s oral …
Padagis Israel Pharmaceuticals Ltd reported the approval of its 505(b)(2) application (and label extension) for topical clindamycin phosphate to market a generic version of Cleocin…
# FDA Approves Baxter Healthcare's Liposomal Doxorubicin Formulation Baxter Healthcare Company received FDA approval for its liposomal doxorubicin hydrochloride formulation on Nov…
Pfizer secured FDA approval for the generic formulation of its blockbuster antibiotic Zithromax, a move that is expected to drive immediate market competition in the azithromycin d…
# FDA Approves Hospira's Lidocaine Hydrochloride for Epidural Use Hospira, Inc. received FDA approval for its lidocaine hydrochloride epidural formulation, expanding the company's…
Kenvue Brands LLC noted today that the U.S. Food and Drug Administration recognizes Children’s Motrin (ibuprofen oral solution) as stable for up to 70 months, a critical label upda…
The FDA has re-approved CELLCEPT (mycophenolate mofetil) following the transfer of the NDA to global markets, ensuring Genentech maintains continued exclusivity and market protecti…
Hikma Pharmaceuticals USA Inc. secured FDA approval for Intravenous Acetazolamide Sodium in 1995, expanding its generic portfolio into the IV segment and positioning the company to…
Actavis Pharma, Inc. received FDA approval for its generic glipizide oral tablet, positioning the company to enter the competitive oral anti-diabetic market segment. The clearance …
GlaxoSmithKline announced the FDA approval of oral Atovaquone (Mepron) for the treatment of Pneumocystis pneumonia, a strategic addition expected to broaden the company’s portfolio…
# FDA Approves Hikma Generic Drug Application Hikma Pharmaceuticals has received FDA approval for an abbreviated new drug application (ANDA 074060), positioning the company to exp…
# FDA Approves Sandoz's Apraclonidine for Ophthalmic Use Sandoz Inc. received FDA approval for apraclonidine hydrochloride, an ophthalmic treatment that expands the company's port…
# FDA Approves Baxter Healthcare's Vancomycin Hydrochloride for Intravitreal Injection Baxter Healthcare Corporation received FDA approval for Vancomycin Hydrochloride as an intra…
Hikma Pharmaceuticals USA Inc. secured the approval of a new generic version of LEUCOVORIN CALCIUM, an essential drug indicated for rescue following methotrexate toxicities, potent…
Hikma Pharmaceuticals USA Inc. has announced the approval of its Abbreviated New Drug Application (ANDA) for leucovorin calcium oral, a therapeutic agent generically known for its …
Rhodes Pharmaceuticals LLC announced that the U.S. Food and Drug Administration has granted approval for the **DILAUDID** (Hydromorphone Hydrochloride) oral solution, keeping the p…
ANI Pharmaceuticals, Inc. announced FDA approval of its oral Valproic Acid generic (ANDA073178), a development that further diversifies the company's product portfolio and strength…