Reddy & #39;S Gets Tentative Nod From Us Fda For 2 Drugs

Dr Reddy's Laboratories has received tentative approvals from United States Food and Drugs Administration for Omeprazole 40 mg capsules and Fluoxetine 40 mg capsules on June 27.

Dr Reddy's has stated in a release that it believes it is the first company to file status on both the capsules and will receive 180-day marketing exclusivity on successful outcome of the patent litigation.

The company is fighting patent litigations with the inventors of both the products, namely Eli Lilly and Astra Zeneca, respectively.

Dr Reddy's to market the Fluoxetine capsules through Pharmaceutical Resources Inc, while the Omeprazole capsules will be marketed by the company itself.

Dr Reddy's is also in the process of establishing its own generic sales and marketing organisation for the US market to market its products in the future. As of now, the company has got final FDA approval for 4 products and tentative FDA approval for another four products in the formulations segment.

According to the company's release, Eli Lilly filed another complaint on June 26 against Dr Reddy's as a consequence of filing a certification IV against all Orange Book patents on its Abbreviated New Drug Application (ANDA) filing for Olanzapine 15 mg and 20 mg tablets.

Meanwhile, company officials have also refuted a statement made by the Reserve Bank of India on the company reaching its upper limit of foreign institutional investments.

The RBI on Thursday had notified in a press release that no further purchase of equity shares of Dr Reddy's Laboratories should be made on behalf of the foreign institutional investors on the exchanges without its prior approval as the company had reached its upper limit of 28 per cent.

However the company spokesperson said, "The foreign institutional investors holding as of June 22nd stands at 18.74 per cent of the issued and paid-up capital of over 38201280 shares."

Shares of Dr Reddy's Laboratories closed at a high of Rs 1,610 against previous day's close of Rs 1,577.75.

"The FDA approvals will help the company as it is sure to have good impact on sales and profitability for Dr Reddy's. The scrip has certainly moved up due to the clarification by the company as it had created a lot of confusion yesterday when dealers got information of the RBI statement," a pharma analyst said.