Indian drug major Dr Reddy's Laboratories has launched its
over-the-counter (OTC) fexofenadine HCl tablets.The Food & Drug
Administration (FDA) approved Dr Reddy's Abbreviated New Drug
Application (ANDA) for fexofenadine HCl tablets on April 12, 2011.
Dr Reddy's will market the product under store brand
labels in the U.S. market. The products are bioequivalent versions of
sanofi-aventis' Allegra tablets which received Rx-to-OTC switch
approval from the FDA on January 24, 2011.The fexofenadine HCl Rx
market had brand and generic sales of approximately $452 million
2,012 crore) for the 12 months ending December 31, 2010 according to
Ranbaxy launches generic olanzapine
In a major step aimed at the treatment of schizophrenia in
adults, India's largest pharmaceutical company, Ranbaxy Laboratories
announced the launch of olanzapine tablets, the generic version of
zyprexa in Spain. Ranbaxy will be introducing olanzapine tablets 2.5
mg, 5 mg, 7.5 mg and 10 mg and also orodispersables in 5 mg and 10 mg.
According to IMS data of 2010, zyprexa is the innovator product of Eli
Lilly. Ranbaxy received necessary regulatory approvals from the Spanish
Health Authorities to manufacture and market olanzapine in Spain and is
expected to launch the product on day-1, following patent expiry.
Olanzapine is an atypical antipsychotic, and is indicated for the
treatment of schizophrenia in adults. The product is effective in
maintaining the clinical improvement during continuation therapy in
patients who have shown an initial positive response. Olanzapine is
also indicated for the treatment of moderate to severe manic episodes
and prevents their recurrence. It is also indicated for the treatment
of several bipolar disorders.
MSD and Sun Pharma collaborate
Merck Sharp & Dohme Corporation (MSD), India, entered
into a strategic partnership with Sun Pharmaceutical Industries to
co-market its diabetes drugs in India. Sitagliptin and sitagliptin plus
metformin are the two diabetes drugs which would be marketed by Sun
Pharmaceuticals in India.
Under the partnership arrangement, Sun Pharmaceutical Industries will
have the rights to market, promote and distribute sitagliptin and
sitagliptin plus metformin only in India under different brand names.
This India-specfic partnership agreement aims at delivering treatment
benefits of DPP4 inhibitors to an expanded base of diabetic patients.
Keeping in mind the increasing number of diabetic patients in the
country, this partnership will focus on the interest of patients of
type-2 diabetes in India.