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# FDA Approves Generic Irbesartan and Hydrochlorothiazide from Solco Healthcare Solco Healthcare US, LLC has received FDA approval for a generic formulation of irbesartan and hydr…
Senores Pharma secured FDA approval for its generic product, a move that is expected to bolster the company’s revenue stream while introducing immediate competitive pressure within…
# FDA Approves Upsher-Smith's Topiramate Oral Formulation Upsher-Smith Laboratories, LLC received FDA approval for its oral topiramate formulation (NDA 205122) on March 11, 2014, …
Lupin Pharmaceuticals, Inc. secured FDA approval on March 5, 2014, for its generic Doxycycline oral tablets, positioning the company to capture market share in the commodity antibi…
# FDA Approval Newswire Washington University School of Medicine has received FDA approval for AMMONIA N-13 (NH3N13), an intravenous diagnostic radiopharmaceutical that expands th…
Sankalp Lifecare announced FDA approval for its new drug application, a milestone that is expected to diversify the company's revenue streams and strengthen its competitive positio…
# FDA Approves AstraZeneca's FARXIGA for Diabetes Treatment AstraZeneca Pharmaceuticals LP received FDA approval for FARXIGA (dapagliflozin), an oral diabetes medication that expa…
Sun Pharma received FDA approval for an Abbreviated New Drug Application, a regulatory clearance expected to facilitate generic market entry and drive incremental revenue growth.
Mylan Pharmaceuticals Inc. received FDA approval for its generic version of the cardiovascular drug Amlodipine and Atorvastatin, offering a cost-effective alternative to branded co…
Fresenius Kabi secured FDA approval for its intramuscular morphine sulfate formulation, significantly expanding its therapeutic options within the competitive injectable analgesics…
# FDA Approves ANDA for AUROLIFE PHARMA LLC AUROLIFE PHARMA LLC has received FDA approval for ANDA 202580, expanding its generic drug portfolio and positioning the company to capt…
HIKMA Pharmaceuticals announced the FDA approval of its Generic ANDA application, a strategic milestone expected to bolster market share and expand revenue within the competitive U…
PH HEALTH has secured FDA approval for the pending generic application ANDA090733, a move that positions the company to capture new market share and diversify its revenue streams u…
Actavis Elizabeth’s FDA approval of this ANDA clears the regulatory path for a generic entry, positioning the company to compete aggressively against the brand product and erode it…
# 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…
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…