Actavis
FDA Approves ACYCLOVIR — Actavis Pharma, Inc.
Actavis Pharma’s FDA approval of the generic oral Acyclovir is expected to intensify competitive pricing within the antiviral market, potentially pres...
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JANSSEN
FDA Approves Unknown Drug — JANSSEN PHARMS
Janssen Pharmaceuticals received regulatory approval for a new drug on February 21, 1997; the breakthrough has the potential to significantly influenc...
Pfizer
FDA Approves ZITHROMAX — Pfizer Laboratories Div Pfizer Inc
Pfizer has announced that ZITHROMAX (azithromycin dihydrate), confirmed by the 1997 intravenous approval, remains a cornerstone of its broad-spectrum ...
Hospira,
FDA Approves SUFENTANIL CITRATE — Hospira, Inc.
FDA oncology advisory committee voted to recommend for approval Hospira Inc.’s generic version of the ultra-potent synthetic opioid sufentanil citrate...
Hikma
FDA Approves DIPYRIDAMOLE — Hikma Pharmaceuticals USA Inc.
# FDA Approves Hikma Pharmaceuticals' Intravenous Dipyridamole Hikma Pharmaceuticals USA Inc. received FDA approval for its intravenous dipyridamole ...
PH
FDA Approves Unknown Drug — PH HEALTH
PH HEALTH announced FDA approval of its new generic application ANDA040105 on July 30, 1996, signaling the company's strategic entry into the branded ...
Haleon
FDA Approves CHILDRENS ADVIL — Haleon US Holdings LLC
# FDA Approves Children's Advil (Ibuprofen) for Haleon US Holdings LLC The FDA approval of Children's Advil marks Haleon US Holdings LLC's entry into...
US
FDA Approves Unknown Drug — US ANTIBIOTICS
FDA has granted approval to US Antibiotics for the industrial manufacturing and distribution of pharmaceutical products, a move expected to expand the...
PAI
FDA Approves Unknown Drug — PAI HOLDINGS
PAI Holdings announced today that the FDA has approved the 1996-era ANDA referencing NDA058389, a development likely aimed at enhancing product availa...
TerSera
FDA Approves ZOLADEX — TerSera Therapeutics LLC
# FDA Approves ZOLADEX (Goserelin Acetate) for TerSera Therapeutics TerSera Therapeutics LLC has received FDA approval for ZOLADEX (goserelin acetate...
TERSERA
FDA Approves Unknown Drug — TERSERA
# FDA Approves TERSERA Drug Application TERSERA has received FDA approval for a new drug application (NDA020515), marking a significant entry into th...
Kenvue
FDA Approves ZYRTEC HIVES — Kenvue Brands LLC
Kenvue Brands LLC has announced that the FDA has approved the antihistamine Cetirizine Hydrochloride (ZYRTEC HIVES) via BLA NDA019835. This approval s...
Padagis
FDA Approves CLINDAMYCIN PHOSPHATE — Padagis Israel Pharmaceuticals Ltd
Padagis Israel Pharmaceuticals Ltd reported the approval of its 505(b)(2) application (and label extension) for topical clindamycin phosphate to marke...
Baxter
FDA Approves DOXORUBICIN HYDROCHLORIDE LIPOSOME — Baxter Healthcare Company
# FDA Approves Baxter Healthcare's Liposomal Doxorubicin Formulation Baxter Healthcare Company received FDA approval for its liposomal doxorubicin hy...
Hospira,
FDA Approves LIDOCAINE HYDROCHLORIDE — Hospira, Inc.
# FDA Approves Hospira's Lidocaine Hydrochloride for Epidural Use Hospira, Inc. received FDA approval for its lidocaine hydrochloride epidural formul...
Kenvue
FDA Approves CHILDRENS MOTRIN — Kenvue Brands LLC
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...
Genentech,
FDA Approves CELLCEPT — Genentech, Inc.
The FDA has re-approved CELLCEPT (mycophenolate mofetil) following the transfer of the NDA to global markets, ensuring Genentech maintains continued e...
Hikma
FDA Approves ACETAZOLAMIDE — Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc. secured FDA approval for Intravenous Acetazolamide Sodium in 1995, expanding its generic portfolio into the IV segment ...
Actavis
FDA Approves GLIPIZIDE — Actavis Pharma, Inc.
Actavis Pharma, Inc. received FDA approval for its generic glipizide oral tablet, positioning the company to enter the competitive oral anti-diabetic ...
GlaxoSmithKline
FDA Approves MEPRON — GlaxoSmithKline LLC
GlaxoSmithKline announced the FDA approval of oral Atovaquone (Mepron) for the treatment of Pneumocystis pneumonia, a strategic addition expected to b...