SUN
FDA Approves Unknown Drug — SUN PHARM INDUSTRIES
SUN PHARM INDUSTRIES announced FDA approval for ANDA040260, securing a regulatory milestone that adds a new generic option to its portfolio and positi...
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Celgene
FDA Approves THALOMID — Celgene Corporation
Celgene Corporation rallied on July 16, 1998, following the FDA's approval of its oral Thalomid (thalidomide) therapy, marking a pivotal moment for th...
Rhodes
FDA Approves MORPHINE SULFATE EXTENDED RELEASE — Rhodes Pharmaceuticals LLC
Rhodes Pharmaceuticals announced the FDA approval of its Morphine Sulfate Extended Release tablets, adding a high-volume product to its generic portfo...
Rhodes
FDA Approves MORPHINE SULFATE EXTENDED RELEASE — Rhodes Pharmaceuticals LLC
Rhodes Pharmaceuticals LLC obtained FDA clearance to market Morphine Sulfate Extended Release, a generic entry poised to capture market share from the...
Acertis
FDA Approves PROMETRIUM — Acertis Pharmaceuticals, LLC
# FDA Approves Progesterone Oral Formulation for Acertis Pharmaceuticals Acertis Pharmaceuticals, LLC has received FDA approval for PROMETRIUM (proge...
Allergan,
FDA Approves ACTONEL — Allergan, Inc.
# FDA Approves Allergan's ACTONEL (Risedronate Sodium) for Oral Administration Allergan, Inc. has received FDA approval for ACTONEL (risedronate sodi...
ANI
FDA Approves Unknown Drug — ANI PHARMS
ANI PHARMS has announced the successful approval of its ANDA filing, enabling the company to capitalize on forecasted market opportunities in the gene...
Cumberland
FDA Approves KRISTALOSE — Cumberland Pharmaceuticals Inc.
# FDA Approves Cumberland Pharmaceuticals' KRISTALOSE (Lactulose) for Oral Administration Cumberland Pharmaceuticals Inc. received FDA approval for K...
SANDOZ
FDA Approves Unknown Drug — SANDOZ
# Sandoz Receives FDA Approval for Generic Drug Sandoz has received FDA approval for a generic drug formulation under ANDA040194, expanding the compa...
Sanofi-Aventis
FDA Approves AVAPRO — Sanofi-Aventis U.S. LLC
SAINT-LEU-LO-D'ENFER, France – Sanofi lifecycle management activities bolstered by the FDA approval of IVIRBESARTAN are poised to extend the commercia...
Epic
FDA Approves LEUCOVORIN CALCIUM — Epic Pharma LLC
Epic Pharma LLC announced the launch of Leucovorin Calcium as an oral supplement for an ANDA filed in 1997, strengthening its portfolio of chemotherap...
WATSON
FDA Approves Unknown Drug — WATSON LABS
Watson Labs received FDA approval for this application, an event that enhances its competitive positioning within the generic pharmaceutical market....
Genentech,
FDA Approves CELLCEPT — Genentech, Inc.
Following the expiration of key patents covering Mycophenolate Mofetil, market leaders such as Genentech, Inc. and its partner Roche will face increas...
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...
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...