FDA Approves PROMETRIUM — Acertis Pharmaceuticals, LLC
# FDA Approves Progesterone Oral Formulation for Acertis Pharmaceuticals Acertis Pharmaceuticals, LLC has received FDA approval for PROMETRIUM (progesterone oral capsules), expand…
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# FDA Approves Progesterone Oral Formulation for Acertis Pharmaceuticals Acertis Pharmaceuticals, LLC has received FDA approval for PROMETRIUM (progesterone oral capsules), expand…
# FDA Approves Allergan's ACTONEL (Risedronate Sodium) for Oral Administration Allergan, Inc. has received FDA approval for ACTONEL (risedronate sodium hemipentahydrate), an oral …
ANI PHARMS has announced the successful approval of its ANDA filing, enabling the company to capitalize on forecasted market opportunities in the generic sector. The green light pr…
# FDA Approves Cumberland Pharmaceuticals' KRISTALOSE (Lactulose) for Oral Administration Cumberland Pharmaceuticals Inc. received FDA approval for KRISTALOSE, an oral lactulose f…
# Sandoz Receives FDA Approval for Generic Drug Sandoz has received FDA approval for a generic drug formulation under ANDA040194, expanding the company's portfolio in the competit…
Watson Laboratories has received important FDA approval for an abbreviated new drug application (ANDA040171), paving the way for the entry of a 1997-vintage generic into the market…
SAINT-LEU-LO-D'ENFER, France – Sanofi lifecycle management activities bolstered by the FDA approval of IVIRBESARTAN are poised to extend the commercial life of the popular antihype…
Epic Pharma LLC announced the launch of Leucovorin Calcium as an oral supplement for an ANDA filed in 1997, strengthening its portfolio of chemotherapy support formulations and inc…
Watson Labs received FDA approval for this application, an event that enhances its competitive positioning within the generic pharmaceutical market.
Following the expiration of key patents covering Mycophenolate Mofetil, market leaders such as Genentech, Inc. and its partner Roche will face increasing revenue pressure and heigh…
Actavis Pharma’s FDA approval of the generic oral Acyclovir is expected to intensify competitive pricing within the antiviral market, potentially pressuring market share for the re…
Janssen Pharmaceuticals received regulatory approval for a new drug on February 21, 1997; the breakthrough has the potential to significantly influence the company's revenue stream…
Pfizer has announced that ZITHROMAX (azithromycin dihydrate), confirmed by the 1997 intravenous approval, remains a cornerstone of its broad-spectrum antibiotic portfolio despite l…
Generics giant Teva Neuroscience announced the regulatory approval of its generic glatiramer acetate, bringing a widely used treatment for multiple sclerosis to market following th…
FDA oncology advisory committee voted to recommend for approval Hospira Inc.’s generic version of the ultra-potent synthetic opioid sufentanil citrate for epidural use, a decision …
# FDA Approves Hikma Pharmaceuticals' Intravenous Dipyridamole Hikma Pharmaceuticals USA Inc. received FDA approval for its intravenous dipyridamole formulation, expanding the com…
PH HEALTH announced FDA approval of its new generic application ANDA040105 on July 30, 1996, signaling the company's strategic entry into the branded or complex manufacturing secto…
# 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 the pediatric pain relief mar…
FDA has granted approval to US Antibiotics for the industrial manufacturing and distribution of pharmaceutical products, a move expected to expand the company's supply capabilities…
PAI Holdings announced today that the FDA has approved the 1996-era ANDA referencing NDA058389, a development likely aimed at enhancing product availability and broadening market c…