FDA Approves Unknown Drug — SUN PHARM INDUSTRIES
Sun Pharmaceutical Industries secured FDA approval for a generic medication under ANDA205634, a development expected to strengthen the company’s competitive positioning and drive f…
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Sun Pharmaceutical Industries secured FDA approval for a generic medication under ANDA205634, a development expected to strengthen the company’s competitive positioning and drive f…
Naloxone and buprenorphine tablets, sold under the brand name Buprenex by Sun Pharmaceutical Industries, Inc., were granted FDA approval on August 5, 2016. This authorization expan…
Amneal Pharmaceuticals has secured FDA approval for methylphenidate hydrochloride, the generic version of the widely prescribed attention-deficit hyperactivity disorder treatment. …
# FDA Approves Sanofi-Aventis Biologic Drug The U.S. Food and Drug Administration has approved a new biologic drug from Sanofi-Aventis US (BLA208471), potentially strengthening th…
On July 19, Rising Pharma Holdings, Inc. announced the FDA approval of its generic version of rosuvastatin calcium, placing the company in a competitive position to capitalize on t…
Glenmark Pharmaceuticals Inc. USA has received FDA approval for the oral route rosuvastatin calcium ANDA, entering the generic market for the highly prescribed cholesterol-lowering…
SUN PHARMaceuticals has received approval for the new drug application #ANDA079169, a development that is poised to expand the company’s footprint in the specific therapeutic secto…
Trigen Laboratories, LLC announced the FDA approval of its ANDA for oral hydromorphone hydrochloride tablets, adding a new generic entrant to the strong opioid analgesic market. Th…
Stride Pharma International announced approval of its Abbreviated New Drug Application (ANDA) on July 5, 2016, indicating regulatory clearance to enter the market, though specific …
On June 23, Mylan Pharmaceuticals Inc. was granted FDA approval for the Abbreviated New Drug Application #ANDA204475 for tablet and capsule forms of Fenofibrate Oral. This approval…
Ingenus Pharmaceuticals announced today that it received FDA approval for the ANDA206043, granting market exclusivity to its generic version of Primaquine Phosphate. This approval …
Strides Pharma Science Limited announced the FDA approval of its generic Hydrocodone Bitartrate and Acetaminophen products, a move anticipated to invite immediate price competition…
# FDA Approves Generic Irbesartan from Hisun Pharmaceuticals USA Inc. The FDA has approved Hisun Pharmaceuticals USA Inc.'s generic formulation of irbesartan, an oral antihyperten…
Fresenius Kabi USA, LLC has received approval for the intravenous formulation of fosaprepitant dimeglumine (ANDA 206,197), which provides an alternative supply for branded emergenc…
# FDA Approves Generic Hydrocodone Bitartrate and Ibuprofen Combination Aurolife Pharma, LLC has received FDA approval for a generic version of the hydrocodone bitartrate and ibup…
Actavis Labs Florida, Inc. secured FDA approval for its generic sildenafil citrate tablets (20 mg), clearing the way for a competitive launch in the Pulmonary Arterial Hypertension…
The FDA has approved a supplementary ANDA for oral atorvastatin calcium by Cipla USA Inc., allowing the company to expand its generic cholesterol-lowering offerings. This clearance…
Sun Pharmaceutical Industries has secured approval for the topical formulation of Fluocinolone Acetonide based on the company’s ANDA 209336, solidifying its footprint in the cortic…
# FDA Approves Genentech's TECENTRIQ (atezolizumab) for Bladder Cancer Genentech, Inc. received FDA approval for TECENTRIQ (atezolizumab), a PD-L1 inhibitor administered intraveno…
Pharmobedient Continues Regulatory Expansion Pharmobedient has expanded its product portfolio with this latest FDA approval, positioning itself for broader market penetration withi…