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# FDA Approves Novartis's TAFINLAR (Dabrafenib) for Melanoma Treatment Novartis Pharmaceuticals Corporation received FDA approval for TAFINLAR (dabra...
PAI Holdings has secured FDA approval for its ANDA 040838, facilitating the market launch of hydrocodone bitartrate and acetaminophen, a widely utiliz...
On April 15, 2013, Aurolife Pharma, LLC received FDA approval for the ANDA representing acetaminophen and codeine phosphate tablets. This authorizatio...
Janssen Pharmaceuticals received FDA approval for INVOKANA, a novel SGLT2 inhibitor for the treatment of type 2 diabetes, which is poised to capture s...
Cranbury Pharmaceuticals, LLC received FDA approval for its ANDA covering Tramadol Hydrochloride tablets, granting the company authorization to market...
# FDA Approves Generic Olanzapine and Fluoxetine Combination Teva Pharmaceuticals USA, Inc. received FDA approval for a generic version of the olanza...
# FDA Approves BluePoint Laboratories' Generic Isotretinoin (Zenatane) BluePoint Laboratories received FDA approval for Zenatane (isotretinoin) oral ...
# FDA Approves Generic Drug Application for Sun Pharmaceutical Sun Pharmaceutical Industries Ltd. received FDA approval for ANDA091037 on February 22...
Genentech announced today that the FDA has approved KADCYLA, an antibody-drug conjugate for HER2-positive breast cancer, signaling a strategic expansi...
Actavis Pharma, Inc. has secured FDA approval for its **buprenorphine and naloxone** (generic) tablets/sublingual film, expanding the availability of ...
# FDA Approves Celgene's POMALYST (pomalidomide) for Multiple Myeloma Treatment Celgene Corporation received FDA approval for POMALYST (pomalidomide)...
Chartwell RX LLC announced FDA approval for its generic Calcium Acetate oral tablets, positioning the company to enter the competing marketplace for p...
Actavis Pharma, Inc. has received FDA approval for its Abbreviated New Drug Application (ANDA) for morphine sulfate oral solid dosage forms, potential...
Micro Labs Limited secured FDA approval for its Tramadol Hydrochloride and Acetaminophen oral tablet formulation, expanding its product portfolio in t...
FDA approved XELJANZ (tofacitinib citrate) from Pfizer Laboratories, a new oral treatment for rheumatoid arthritis, paving the way for the company to ...
# FDA Approves Par Pharmaceutical's Generic Olanzapine and Fluoxetine Combination Par Pharmaceutical's approval of generic olanzapine and fluoxetine ...
# FDA Approves NextWave Pharmaceuticals' QUILLIVANT XR for ADHD Treatment NextWave Pharmaceuticals, Inc. received FDA approval for QUILLIVANT XR (met...
# FDA Approves Sandoz Generic Drug Application Sandoz received FDA approval for ANDA 077446 on September 27, 2012, expanding its generic pharmaceutic...
# FDA Approves Losartan Potassium Generic from Micro Labs Limited Micro Labs Limited has received FDA approval for its generic formulation of losarta...
Lupin Pharmaceuticals, Inc. secured FDA approval for generic Escitalopram Oxalate oral tablets, expanding its portfolio in the widely utilized antidep...