FDA Approves ZENATANE — BluePoint Laboratories
# FDA Approves BluePoint Laboratories' Generic Isotretinoin (Zenatane) BluePoint Laboratories received FDA approval for Zenatane (isotretinoin) oral formulation under ANDA 202099,…
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# FDA Approves BluePoint Laboratories' Generic Isotretinoin (Zenatane) BluePoint Laboratories received FDA approval for Zenatane (isotretinoin) oral formulation under ANDA 202099,…
# FDA Approves Generic Drug Application for Sun Pharmaceutical Sun Pharmaceutical Industries Ltd. received FDA approval for ANDA091037 on February 22, 2013, expanding its generic …
Genentech announced today that the FDA has approved KADCYLA, an antibody-drug conjugate for HER2-positive breast cancer, signaling a strategic expansion in the oncology portfolio t…
# FDA Approves Celgene's POMALYST (pomalidomide) for Multiple Myeloma Treatment Celgene Corporation received FDA approval for POMALYST (pomalidomide), an oral immunomodulatory age…
Chartwell RX LLC announced FDA approval for its generic Calcium Acetate oral tablets, positioning the company to enter the competing marketplace for phosphate binders used in chron…
Actavis Pharma, Inc. has received FDA approval for its Abbreviated New Drug Application (ANDA) for morphine sulfate oral solid dosage forms, potentially broadening access to this c…
Micro Labs Limited secured FDA approval for its Tramadol Hydrochloride and Acetaminophen oral tablet formulation, expanding its product portfolio in the U.S. pain management market…
# FDA Approves Par Pharmaceutical's Generic Olanzapine and Fluoxetine Combination Par Pharmaceutical's approval of generic olanzapine and fluoxetine (ANDA077742) on November 2, 20…
# FDA Approves NextWave Pharmaceuticals' QUILLIVANT XR for ADHD Treatment NextWave Pharmaceuticals, Inc. received FDA approval for QUILLIVANT XR (methylphenidate hydrochloride), a…
# FDA Approves Sandoz Generic Drug Application Sandoz received FDA approval for ANDA 077446 on September 27, 2012, expanding its generic pharmaceutical portfolio and positioning t…
# FDA Approves Losartan Potassium Generic from Micro Labs Limited Micro Labs Limited has received FDA approval for its generic formulation of losartan potassium, an oral antihyper…
Lupin Pharmaceuticals, Inc. secured FDA approval for generic Escitalopram Oxalate oral tablets, expanding its portfolio in the widely utilized antidepressant market. This regulator…
# FDA Approval Newswire The FDA has approved Chartwell RX, LLC's generic formulation of Ziprasidone Hydrochloride for oral administration, expanding the competitive landscape in t…
Aurobindo Pharma Limited received FDA approval for the generic formulation of its ALFUZOSIN HYDROCHLORIDE oral tablets, broadening the company’s portfolio and introducing immediate…
# FDA Approves Generic Losartan Potassium and Hydrochlorothiazide Combination Macleods Pharmaceuticals Limited received FDA approval for its generic losartan potassium and hydroch…
Alvogen, Inc. received FDA approval on Thursday for a generic version of Oxycodone and Acetaminophen tablets, enabling the company to enter the established market for this widely p…
# FDA Approves Fluorouracil IV from Eugia US LLC The FDA has approved Eugia US LLC's intravenous fluorouracil formulation (ANDA 202668), adding another generic option to the compe…
# FDA Approves Generic Fluorouracil Intravenous Formulation The FDA approved Eugia US LLC's abbreviated new drug application for generic fluorouracil intravenous injection on July…
# FDA Approves Genentech's PERJETA (Pertuzumab) for HER2-Positive Breast Cancer Genentech, Inc. has received FDA approval for PERJETA (pertuzumab), a novel HER2-targeted therapy a…
Sun Pharmaceutical Industries’ 2012 approval of Absorica (isotretinoin) strengthened the company's market position in the dermatology sector by introducing a branded generic altern…