Aurobindo gets US FDA approval for generic lamotrigine (Lamictal) pills

Indian API and generics firm Aurobindo Pharma Ltd  has received the final approval for selling a generic version of the epilepsy drug, lamotrigine  from the U.S Food and Drug Administration.

US FDA approved Aurobindo’s abbreviated new drug application (ANDAs) for lamotrigine pills  in 5-milligram and 25-mg tablets strengths in chewable, dispersible form, Aurobindo said in a statement to the Bombay Stock Exchange.

Aurobindo’s lamotrigine is a generic equivalents to Lamictal CD tablets of GlaxoSmithKline PLC’s.

Lamotrigine tablet is indicated as adjunctive therapy for partial seizures and generalised seizures of Lennox-Gastaut syndrome in patients aged 2 years and older, and for conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing antiepileptic drug.

Lamotriginefalls under the CNS (Central Nervous System) segments.

The 2002 American Psychiatric Association guidelines recommended lamotrigine as a first-line treatment for acute depression in bipolar disorder as well as a maintenance therapy.

Teva Pharmaceutical Industries Ltd launched generic Lamotrigine in the United States in 2005in 5 mg and 25 mg chewable dispersible tablets. In 2008 Teva began offering the full range of generic Lamotrigine in the US.

Lamotrigine is Aurobindo’s 107the approval in US.

As on 30.09.2009, Aurobindo’s 106 ANDAs have been approved in USA including 29 tentative approvals.

Aurobindo has so far launched 59 products in the USA market.

Headquartered at Hyderabad, India, Aurobindo Pharma Limited manufactures generic pharmaceuticals and active pharmaceutical ingredients.

Aurobindo Pharma ’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.

Aurobindo Pharma’s product portfolio is spread over 6 major therapeutic/product areas encompassing antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals, and anti-allergics.

Aurobindo Pharma has alliances with original research companies in the area of custom synthesis.

Aurobindo Pharma offers a comprehensive custom synthesis services in organic custom synthesis and chemical development. All the six manufacturing plants of the company conform to international standards, with a variety of reactors – more than 300 SS, glass lined, high pressure and sterile reactors, spray drier, and hydrogenators. All are cGMP compliant.

Under the organic custom synthesis module, Aurobindo offers a full range of services to meet the varying needs by utilizing established synthetic routes, modifying customer processes, designing novel routes with complete chemical, chromatographic, spectroscopic back up for starting materials, intermediates, reference compounds, metabolites, resolution of enantiomers, structural isomers etc.

As part of the chemical development service, Aurobindo offers scale-up of existing processes, preparation of intermediates in milligrams to kilo lots, processes optimization, development and use of purification techniques and alternate process routes.
Aurobindo is planning to launch generic lamotrigine pills in the US market soon.

Aurobindo Pharma posted net profit of Rs 128.29 crore in Q2 September 2009 as against a net loss of Rs 38.50 crore in the same quarter last year.

Aurobindo Pharma’s net sales rose 30% to Rs 826.31 crore in Q2 September 2009 over Q2 September 2008.

During the quarter ended September 2009, the company incurred a foreign exchange loss of Rs 3.70 crore.

Aurobindo Pharma Ltd’s gross margin improved to 52.2% from 49.1% last year and operating profit before Fx improves to 23.5% in comparison with 17.6% last year.

Aurobindo Pharma’s operating profit (EBIDTA) before Fx up 65.7% to Rs 207.0 crores from last year’s 124.9 crore. PBT before Fx up by 95.5% to Rs 164.6 crores against Rs 84.2 crores.

Aurbindo Pharma’s PAT before Fx up by 60.1% to Rs 106.8 crores against Rs 66.7 crores.

Aurobindo’s formulation sales went up by 39.4% to Rs 445.2 crores against Rs 319.3 crores a year ago. Formulations sales constitute 51.3% against 44.1% of gross sales.