Dr Reddy's Laboratories, an India-based pharmaceutical company, has introduced Donepezil Hydrochloride tablets 23mg in the US on 26 July 2013. The launch follows the approval of an abbreviated new drug application (ANDA) for the drug by ...
Tags: Drug Aricept, Generic Equivalent
Mylan Pharmaceuticals and Orion have entered into a settlement and license agreement, which dismisses the parties pending litigation related to Mylan's filing of an Abbreviated New Drug Application (ANDA) with the US FDA for the generic ...
Tags: Mylan, Orion, Generic Version
Mylan Pharmaceuticals has introduced Norethindrone Tablets USP, 0.35mg, which is the generic version of Watson Laboratories' (now Actavis) Nor-Q.D. tablets, 0.35mg for 28-day cycle, for the prevention of pregnancy in the US. The ...
Tags: Generic Contraceptive Pill, Mylan
Mylan Pharmaceuticals, Mylan's US subsidiary, has launched one of the first generic versions of Abbott's Trilipix Capsule in the US. Known as Fenofibric Acid Delayed-release Capsules, 45mg and 135mg is indicated for patients with mixed ...
The USFDA has cleared Actavis' abbreviated new drug application (ANDA) for Lamotrigine orally disintegrating tablets, 25mg, 50mg, 100mg and 200mg. A generic version of GlaxoSmithKline's Lamictal ODT, the antiepileptic drug is indicated ...
Specialty pharmaceutical company Actavis has won FDA approval for abbreviated new drug application (ANDA) of generic equivalent to Endo Health Solutions' Opana ER. Oxymorphone Hydrochloride extended-release tablets, which is available in ...
Tags: FDA, ANDA, Generic Opana ER
US-based Mylan Pharmaceuticals has introduced generic equivalent to Micronor tablets, 0.35mg (28-day cycle) indicated for the prevention of pregnancy in the US. Norethindrone Tablets USP, 0.35mg, are the generic version of Janssen ...
Tags: Generic Micronor Tablets, Medicine
Specialty pharmaceutical company Sun Pharmaceutical Industries has obtained final USFDA approval for the abbreviated new drug application of generic Depo-Testosterone Injection, Testosterone Cypionate Injection USP, 100mg/ml and 200mg/ml. ...
Mylan Pharmaceuticals, the subsidiary of Mylan, has introduced Fenofibrate tablets, 48 mg and 145 mg. The company has received the final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application ...
Tags: Mylan, Generic Version
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Zolmitriptan tablets, 2.5mg and 5mg. The generic equivalent of IPR Pharmaceuticals' Zomig tablets is indicated for the acute treatment of migraine ...
Tags: FDA, Pharmaceuticals
Taiwan-based specialty pharmaceutical company TWi Pharmaceuticals has obtained FDA tentative approval for its abbreviated new drug application (ANDA) for Guanfacine Hydrochloride Extended Release tablets 1mg, 2mg, 3mg and 4mg. The central ...
Tags: TWi, FDA, pharmaceutical
Actavis has resolved outstanding patent litigation concerning generic version of Intuniv (guanfacine hydrochloride), indicated for the treatment of attention deficit hyperactivity disorder, with Shire. The settlement agreement also ...
Posted by Jack Mans, Plant Operations Editor -- Packaging Digest, 4/23/2013 5:04:22 PM The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.'s reformulated OxyContin (oxycodone hydrochloride ...
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received FDA approval for its abbreviated new drug application for Vancomycin hydrochloride capsules, USP, 125mg and 250mg. The company has begun the shipment of the product ...
The US FDA has granted final approval for Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Acyclovir Ointment USP, 5%. Acyclovir Ointment is the generic equivalent to Zovirax Ointment from Valeant International. Mylan ...
Tags: FDA, Acyclovir Ointment, Medicine