Orchid gets tentative FDA approval for Alzheimer’s drug
January 8th, 2010 - 6:34 pm ICT by IANSChennai, Jan 8 (IANS) The city based Orchid Chemicals & Pharmaceuticals Friday said it has received tentative approval from US Food and Drug Administration (USFDA) for its drug to treat Alzheimer’s disease.
According to Orchid, the approval is for the 5mg and 10mg memantine hydrochloride tablets, which are determined to be generic equivalent of Forest Laboratories’ Namenda tablets of similar strength.
Memantine is prescribed for the treatment of Alzheimer’s disease.
Orchid filed its abbreviated new drug application (ANDA) for this product under the Paragraph IV, First-to-file (FTF) certification. The product is under patent litigation between Orchid and Forest. The market size for memantine tablets is estimated to be around $1.1 billion.
- Dr Reddy's launches anti-asthma tablets in US - Nov 20, 2010
- Decks cleared for Orchid to market anti-infectives in US - Sep 25, 2009
- Wockardt gets US nod for Tamsulosin capsules - Sep 29, 2009
- Ranbaxy approved to make first generic version of Lipitor - Dec 01, 2011
- Why Alzheimer's drug is both safe and effective - Aug 19, 2010
- Orchid Chemicals signs out-licensing deal with Alvogen - May 05, 2010
- Natco Pharma launches anti-swine flu medicine (Business Capsule) - Sep 18, 2009
- US health regulator approves Chennai drug plant - Jun 22, 2011
- Experts challenge FDA approval for Alzheimer's drug - Mar 25, 2012
- Hotel prices fell by 17 percent: Report (Business Capsule) - Sep 16, 2009
- Ranbaxy's June quarter net profit falls by 25 pc - Aug 05, 2011
- Orchid gets US FDA approval for its drug - Feb 20, 2008
- Ranbaxy settles issue with US health regulator - Dec 21, 2011
- Ranbaxy posts $210 mn net profit - May 11, 2010
- Orchid Chemicals completes business transfer to Hospira - Mar 31, 2010
Tags: 1 billion, abbreviated new drug application, alzheimer, chennai, fda, fda approval, food and drug, food and drug administration, forest laboratories, generic equivalent, memantine, memantine hydrochloride, namenda, orchid chemicals, paragraph, patent litigation, pharmaceuticals, tentative approval, usfda