3 Indian firms get USFDA nod for high-value generic drug

In what could boost their fortunes significantly, three Indian companies - Sun Pharma, Aurobindo Pharma and Glenmark Pharma - have received approval from United States Food & Drug Administration (USFDA) to manufacture and market generic versions of blockbuster cholesterol drug Crestor in the American market.

According to IMS Health, a global information and technology services company, this drug has had annual sales of $6.8 billion in the United States itself.

Crestor - which was under patent of AstraZeneca till date - is the brand name of Rosuvastatin Calcium tablets. It works by controlling bad cholesterol, which can build up in the arteries and obstruct the flow of blood to the heart, brain and other parts of the body. Therefore, it is known to prevent heart disease and strokes in patients with high cholesterol.

On Bombay Stock Exchange, the Sun Pharma shares rose by 1.89 per cent - from Rs 782.20 to Rs 797 - on Wednesday. Shares of Aurobindo Pharma and Glenamrk Pharma saw a jump of 5.09 per cent and 2.39 per cent respectively on Wednesday.

Observing that the patent period for this drug was expiring, the three companies had filed Abbreviated New Drug Application (ANDA) for this drug with USFDA this year. Abbreviated New Drug Applications are "abbreviated" as they do not require the applicant pharmaceutical company to conduct clinical trials and require less information than a New Drug Application.

The three companies received the USFDA approval on Wednesday to manufacture and market generic versions of the drug in four variants - 5 mg (base), 10 mg (base), 20 mg (base) and 40 mg (base).

The drug is not without its major side effects. In May this year, the USFDA published the adverse reactions of a major study conducted on patients taking Crestor. It said the most commonly reported adverse reactions (incidence greater than 2 per cent) in the 'Crestor controlled clinical trial database of 5394 patients' were headache, myalgia (muscle pain), abdominal pain, asthenia (tiredness, loss of energy) and nausea.

In 2012, the USFDA had said that the serious side effects of this drug may be liver problems. "Your health care professional should do blood tests to check your liver before you start taking Crestor and if you have symptoms of liver problems while you take Crestor. Call your doctor right away if you have any of the following symptoms of liver problems: feel unusually tired or weak," said the FDA. It said the additional side effects reported with Crestor are memory loss and confusion.

Aurobindo Pharma stated: "This is the 112th ANDA - including 19 tentative approvals - to be approved out of Unit III formulation facility in Hyderabad, India for manufacturing oral non-Antibiotic products. Aurobindo now has a total of 274 ANDA approvals (234 final approvals including 13 from Aurolife Pharma LLC and 40 tentative approvals) from USFDA."

Glenmark Pharma's current portfolio consists of 115 products authorized for distribution in the U.S. marketplace and 61 ANDA's pending approval with the USFDA. "In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio," said the company spokesperson.