Sun Pharmaceutical Industries announced that it has secured final approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) to market generic Topamax, topiramate tablets.
Topiramate, is a generic version of epilepsy drug Topamax, owned by Ortho-McNeil Pharmaceutical Inc, a division of Johnson & Johnson.
The tablets are available in four different potencies including 25 mg, 50 mg, 100 mg, and 200 mg.
The twelve-monthly sales of Topamax tabs stood at $2.5 billion in the US.
India’s Aurobindo Pharma has notified that it has secured final approval from US Food and Drug Administration (USFDA) for marketing Topiramate tablets.
Aurbindo will market the pills in dosages of 25mg, 50mg, 100mg and 200mg.
The drug is prescribed for the treatment of epilepsy in both children and adults.
In many cases, the drug can also be used as an antidepressant, most of the time for depressive realism. In kids, it is also prescribed for treatment of Lennox-Gastaut syndrome, a disorder that causes seizures and developmental delay.
GlaxoSmithKline Plc (GSK.L) will share over 800 of its patents with researchers trying to make new medicines for tropical diseases, including malaria, and HIV/Aids.
The world's second-largest drug manufacturer also said that it will lessen the price of its drugs in poor nations from next week.
GlaxoSmithKline declared the moves on Tuesday during its annual corporate responsibility report, following a promise by Chief Executive Andrew Witty in an address at Harvard in February 2009 to do more to aid the developing world.
Swiss drug manufacturer Novartis AG made an open offer to purchase an additional equity stake of 39% in its Indian arm Novartis India Ltd. for a total value of up to Rs 440 crore.
The parent company would buy back the shares from public shareholders at INR351 a share.
After the successful completion of this offer, Novartis will hold 90% stake in the Indian arm from the current 50.9%.
Novartis AG made the offer at a premium of 27% to Novartis India’s closing price of Rs 275.6 on March 24.
The country's largest pharmaceutical company, Ranbaxy Laboratories Ltd has managed to get Good Manufacturing Practice (GMP) certificates from the concerned departments in the UK and Australia for its Paonta Sahib plant.
The authorities from both countries investigated the utility as per respective principles and guidelines of GMP in 2006 and finally gave nod to drug manufacturing after re-examining the plant in 2008.