India-based global pharmaceutical company Dr. Reddy's Laboratories has launched Zoledronic Acid injection (4 mg/5 mL), following the approval of its abbreviated new drug application (ANDA) from the Food and Drug Administration, in the US. ...
Tags: pharmaceutical company, pharmaceutical services, pharmaceutical
The USFDA has approved Teva Pharmaceutical Industries' abbreviated new drug application (ANDA) for generic Adderall XR capsules to treat attention deficit hyperactivity disorder. The ANDA is concerned with generic version of Shire's ...
Tags: FDA, Teva Pharmaceutical Industries, ANDA, Adderall XR capsules
The US Food and Drug Administration (FDA) has approved Sun Pharmaceutical Industries' abbreviated new drug application (ANDA) for Doxorubicin HCl Liposome Injection USP, 2 mg/ml. Doxorubicin HCl Liposome Injection USP, 2 mg/ml, which is ...
Tags: FDA, Sun Pharma, Pharmaceutical
The US Food and Drug Administration (FDA) has approved InnoPharma's abbreviated new drug application (ANDA) for acetylcysteine injection. The acetylcysteine injection, which is a generic equivalent of Cumberland Pharmaceuticals' Acetadote ...
Tags: FDA, acetylcysteine injection, Pharmaceuticals, acetaminophen
Famy Care has won final FDA approval for abbreviated new drug application (ANDA) of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15mg/0.03mg, generic equivalent to Teva Branded Pharmaceutical Products' Nordette 28 tablets. Mylan ...
Tags: Medicine
US FDA has approved Watson Pharmaceuticals' abbreviated new drug application (ANDA) for Oxycodone and Acetaminophen tablets, USP 7.5 mg/500 mg and 10 mg/650 mg. The tablets are the generic equivalent to Endo Pharmaceuticals' Percocet ...
Tags: US FDA, ANDA, Watson Pharmaceuticals, Oxycodone and Acetaminophen tablets
Mylan's subsidiary Mylan Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Phenytoin Chewable Tablets USP, 50 mg. Phenytoin is the generic ...
Tags: Mylan, Mylan Pharmaceuticals, US, FDA, ANDA, Phenytoin Chewable Tablets
The US FDA has approved Abbreviated New Drug Application (ANDA) for Breckenridge Pharmaceutical's rizatriptan benzoate tablets. Following the ANDA approval, the company has also annonunced the immediate launch of the tablets. ...
Tags: US FDA, ANDA, Breckenridge Pharmaceutical, rizatriptan benzoate tablets
The US Food and Drug Administration (FDA) has approved Perrigo's abbreviated new drug application (ANDA) for calcium acetate capsules. The generic equivalent of Phoslo Gelcaps are used to treat hyperphosphatemia in patients with end stage ...
Tags: FDA, Perrigo ANDA, calcium acetate capsules
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Quinine Sulfate Capsules USP, 324mg, the generic equivalent to Mutual Pharmaceutical's Qualaquin. Mylan has commenced shipping the generic ...
Tags: FDA, Capsules Anda, Mylan Pharmaceutical, Medicine
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for generic Atacand HCT tablets to treat hypertension. Candesartan Cilexetil and Hydrochlorothiazide Tablets in 16/12.5mg, 32/12.5mg and 32/25mg ...
Tags: US FDA, hypertension medication, ANDA, hypertension
Mylan Pharmaceuticals has signed a settlement agreement with Somaxon Pharmaceutical to resolve patent litigation related to generic version of Somaxon's Silenor. The litigation is regarding Mylan Pharmaceuticals' abbreviated new drug ...
Tags: litigation, generic version of Somaxon's Silenor, ANDA
Mylan has been sued jointly by Pfizer,Wyeth Pharmaceutical,Wyeth LLC and PF Prism regarding the filing of an abbreviated new drug application (ANDA) with the US food and drug administration (FDA) for desvenlafaxine succinate ...
Tags: Mylan, desvenlafaxine succinate extended-release tablets, MDD
Glenmark Generics, a US subsidiary of Glenmark Pharmaceuticals, has received final FDA approval for its abbreviated new drug application for Norgestimate and Ethinyl Estradiol tablets USP 0.25mg/0.035mg. The product is the generic version ...
Teva Pharmaceutical Industries has entered into a settlement agreement related to Nuvigil patent infringement litigation with Mylan. Under the agreement, Mylan is allowed to sell generic versions of 50mg, 150mg, and 250mg Nuvigil in June ...
Tags: Nuvigil, armodafinil tablets, Teva Pharmaceutical Industries, Mylan