FDA Approves FINASTERIDE — Sun Pharmaceutical Industries, Inc.
# FDA Approves Sun Pharmaceutical's Generic Finasteride Sun Pharmaceutical Industries, Inc. received FDA approval for its generic finasteride formulation on July 1, 2013, marking …
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# FDA Approves Sun Pharmaceutical's Generic Finasteride Sun Pharmaceutical Industries, Inc. received FDA approval for its generic finasteride formulation on July 1, 2013, marking …
# FDA Approves Novartis's TAFINLAR (Dabrafenib) for Melanoma Treatment Novartis Pharmaceuticals Corporation received FDA approval for TAFINLAR (dabrafenib mesylate), an oral targe…
PAI Holdings has secured FDA approval for its ANDA 040838, facilitating the market launch of hydrocodone bitartrate and acetaminophen, a widely utilized generic pain reliever. This…
On April 15, 2013, Aurolife Pharma, LLC received FDA approval for the ANDA representing acetaminophen and codeine phosphate tablets. This authorization strengthens the market offer…
Janssen Pharmaceuticals received FDA approval for INVOKANA, a novel SGLT2 inhibitor for the treatment of type 2 diabetes, which is poised to capture significant market share and dr…
Cranbury Pharmaceuticals, LLC received FDA approval for its ANDA covering Tramadol Hydrochloride tablets, granting the company authorization to market the generic version of this p…
# FDA Approves Generic Olanzapine and Fluoxetine Combination Teva Pharmaceuticals USA, Inc. received FDA approval for a generic version of the olanzapine and fluoxetine combinatio…
# 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…
Actavis Pharma, Inc. has secured FDA approval for its **buprenorphine and naloxone** (generic) tablets/sublingual film, expanding the availability of this long-acting opioid agonis…
# 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…
Takeda Pharmaceuticals America, Inc.-sponsored KAZANO (alogliptin and metformin hydrochloride) tablets, an oral antidiabetic drug, received U.S. approval on January 25, 2013. This …
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…
On December 28, 2012, the FDA granted approval to a new drug from Bristol-Myers Squibb, a move that may broaden the company's portfolio and influence competitive dynamics in the ph…
On December 21, 2012, the FDA approved TEDUGLUTIDE (Subcutaneous), developed by Takeda Pharmaceuticals America, Inc., for the treatment of short bowel syndrome; the approval signal…
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 approved XELJANZ (tofacitinib citrate) from Pfizer Laboratories, a new oral treatment for rheumatoid arthritis, paving the way for the company to capture a significant share of…
# FDA Approves Par Pharmaceutical's Generic Olanzapine and Fluoxetine Combination Par Pharmaceutical's approval of generic olanzapine and fluoxetine (ANDA077742) on November 2, 20…